318 Quality Lead jobs in Ireland

Quality Lead & Deputy RP
Full Time Permanent
Annacotty
The Role
Based in Annacotty, Limerick with travel to the depots based in Cork, Sligo and Limerick. The role will support the Uniphar Group Businesses in maintenance of the QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirement and ISO requirements .The role will require a systematic and thorough approach to achieving regulatory compliance through the processes of deviation management, quality risk assessment, and change management.

Main Duties & Responsibilities

• Support the maintenance of the Electronic Quality Management System across the Uniphar Businesses and support the quality team in achieving KPI targets
• Support the quality y team in the management of deviations and CAPAs, risk management, and change control
• Additionally, the role will support as Deputy Responsible Person for the required Wholesale distribution authorisation (s)
• Assist in preparation for Regulatory and Client Audits
• Assist with ISO certification process for the Group entities
• Assist with the integration of QMS into Uniphar Business Units
• Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g. Management Reviews)
• Support maintenance of Licenses including Manufacturing licenses and Wholesale Distribution Authorisation
• Assist with the training of business units on quality and compliance matters
• Support monthly reporting of metrics associated with the Quality Management System
• Accountable for completing activities within required timelines
• Proactively highlight any issues around compliance.
• Happy to engage in challenging assignments

Who We Are
Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar's international reach.

Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access.

With a workforce of close to 3,500 spread across Ireland, United Kingdom, the Netherlands, the Nordics, Germany and the USA, Uniphar is a trusted global partner to Pharma and MedTech manufacturers, working to improve patient access to medicines and treatments around the world.

Culture at Uniphar
We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos. We have built working relationships which span decades with many of the world's largest Pharma and MedTech companies. We believe that this is because we know how to build a relationship of trust with our partners - we put our customers and their patients at the heart of what we do and treat them with integrity and respect. Everything Uniphar does is enabled by our people. As we continue to grow domestically and internationally, we become more diverse. This rich diversity fuels our business and enriches our culture.

About Us
Always open. Our code, our culture, our opportunities. Leading open innovation without limits. We are SUSE.
SUSE is a global leader in innovative, reliable, and secure enterprise open source solutions, including SUSE Linux Suite, SUSE Rancher Suite, SUSE Edge Suite, and SUSE AI Suite. More than 60% of the Fortune 500 rely on SUSE to power their mission-critical workloads, enabling them to innovate everywhere – from the data center to the cloud, to the edge and beyond.

SUSE puts the "open" back in open source, collaborating with partners and communities to give customers the agility to tackle innovation challenges today and the freedom to evolve their strategy and solutions tomorrow. For more information, visit

Data Quality Lead

Job Description
At SUSE, we are committed to leveraging data to drive business growth and innovation. We are looking for a Data Quality Expert to lead the development and execution of our enterprise data quality framework, ensuring data integrity, accuracy, and consistency across the organization.

In this strategic role, you will collaborate with cross-functional teams, data owners, and executive stakeholders to embed data quality best practices, governance, and monitoring into SUSE's data ecosystem. This position is ideal for a data leader who excels in building scalable data quality processes, shaping enterprise-wide standards, and driving business impact through high-quality data.

The role sits within the Enterprise Data Management Team, reporting into the Head of Data Strategy, Governance and Analytics who is Dublin based. Positions can be hybrid or remote.

Key Responsibilities

• Define and implement a scalable, company-wide data quality framework, aligning with data governance and business priorities.
• Establish KPIs and measurement standards to track data accuracy, completeness, and consistency across critical data assets.
• Work closely with data owners, stewards, engineering teams, and business leaders to embed data quality processes in enterprise data management practices.
• Partner with IT and analytics teams to integrate data quality validation checks, anomaly detection, and remediation workflows in BI and analytics platforms (e.g., Power BI, Salesforce Analytics).
• Lead efforts to increase data quality literacy, ensuring stakeholders understand the business impact of poor data quality and their role in maintaining high standards.
• Conduct hands-on data analysis, profiling, and validation to assess and improve data quality when needed.
• Align data quality initiatives with regulatory requirements, internal compliance policies, and industry best practices.
• Identify patterns in data issues, perform root cause analysis, and drive corrective actions to prevent recurring data quality problems.
• Evaluate and recommend data quality tools, working with IT teams to integrate automation and AI-driven data quality solutions.
• Deliver clear insights on data quality health through dashboards, reports, and executive briefings.

Desired Experience & Skills

• Bachelor's degree in Computer Science, Information Systems, or a related field.
• 5+ years of experience in business analysis, with a focus on data-driven environments.
• Proven experience in data quality management, data governance, or data strategy roles in enterprise environments.
• Experience in designing and developing BI solutions, including data modelling, reports, and dashboards using Power BI or other reporting platforms.
• Strong knowledge of data quality frameworks, methodologies, and best practices (e.g., data profiling, DQ dimensions, root cause analysis).
• Experience implementing data quality tools and technologies (e.g., data catalog solutions, data observability platforms, SQL-based data validation).
• Proficient in SQL with experience querying and manipulating data within a data warehouse environment to identify, analyze, and resolve data quality issues independently.
• Familiarity with data governance models and experience working within governance programs.
• Solid understanding of data management principles, metadata management, and data lineage tracking.
• Ability to work at both a strategic and operational level, balancing high-level planning with hands-on execution.
• Strong ability to engage and influence stakeholders at all levels, including C-suite executives, business leaders, and technical teams.
• Strong analytical and problem-solving skills, with the ability to interpret complex data issues and drive strategic resolutions.
• Experience in regulated industries (e.g., finance, technology, SaaS) is a plus.

Personal Attributes

• A meticulous approach to data accuracy, completeness, and governance.
• Skilled at working cross-functionally, breaking down silos, and securing buy-in from senior leaders.
• Always seeking opportunities to improve data processes and quality rather than just identifying issues.
• Comfortable driving cultural change and educating teams on data quality best practices.
• Ability to translate technical data quality concepts into clear, actionable insights for non-technical stakeholders.

Job
Information Technology

What We Offer
We empower you to be bold, driving your career to create the future you want. We celebrate and reward your achievements.

SUSE is a dynamic environment that is evolving rapidly, thus requiring agility, strong entrepreneurship and an open mind.

This is a compelling opportunity for the right person to join us as we continue to scale and prosper.

If you're a big thinker, obsessed by execution and thrive in a dynamic environment in which you can tangibly create a lasting legacy, then please apply now

We give you the freedom to be yourself. You will work in a global community of unique individuals – like you – with different backgrounds, talents, skills and perspectives. A truly open community where everyone is welcome, has a voice and is encouraged to reach their full potential regardless of age, gender, race, nationality, disability, sexual orientation, religion, or any other characteristics.

Sounds like the right fit for you?
Click
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to submit your resume. A recruiter will contact you if your skills match our current or any future positions. In the meantime, stay updated on the latest SUSE news and job vacancies by joining our
Talent Community
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SUSE Values

• Choice
• Innovation
• Trust
• Community

ROLE SUMMARY

Reports to ESOQ Team Leader (Site Quality Operations Lead)

Actively contributes as part of the External Supply Operations Quality T2 structure to ensure that Pfizer's network of External suppliers / CMO's / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines.

ROLE RESPONSIBILITIES

• Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply product(s) to Pfizer according to established procedures.
• Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.
• Supporting internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA or regulatory audits) as applicable
• Supporting onboarding activities of new CMO's or product launches within the portfolio as applicable.
• Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.
• Have the ability to influence quality decision making in line with industry and Pfizer requirements
• Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.
• Ensuring the adequate tracking and documentation of all required quality related actions in the relevant system(s) and ensuring that all required escalation processes are followed.
• Leading and supporting complex investigations / risk assessments in support of products within your portfolio
• Working independently and operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
• Building, maintaining and developing relationships with key stakeholders, both internal and external to Pfizer.

BASIC QUALIFICATIONS

• Minimally Bachelor of Science Degree, Engineering, or related technical discipline
• Minimally 5 years experiences in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 10 years' experience in the pharmaceutical or medical device industry.
• Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault, Documentum platforms
• Proficient in English
• Strong technical writing skills
• Strong verbal, written communication, and presentation skills
• Demonstrated personal leadership to work in virtual teams and in cross functional projects/initiatives
• Is diplomatic, clear & succinct in communication with internal and external stakeholders
• Demonstrated experience managing complex quality and compliance activities
• Demonstrated managerial/organizational skills
• Takes initiatives and is proactive, persistent
• Good organizing and planning skills and a high sense of urgency
• Demonstrated ability to prioritize work, to act and work independently and to report items as required to line manager
• Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices
• Demonstrated technical know how
• Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.

PREFERRED QUALIFICATIONS

• Master's degree and + 10 years relevant pharmaceutical experience.
• Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role
• Experience with external suppliers/contractors
• Candidate demonstrates the ability to influence and collaborate with peers

Work Location Assignment: Hybrid

CLOSING DATE 12 OCTOBER 2025

Additional Information

• In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
• Please note there is no relocation support available for this position

How to apply

• Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you

Purpose

Breakthroughs that change patients' lives. At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here

Quality Assurance and Control

Elite Talent Hub LTD is a specialist in permanent staffing solutions for clients globally.

Our client is a prominent construction company in Ireland, recognized for delivering impactful projects that contribute to the built environment.

With an emphasis on innovation and sustainability, they have grown significantly in the past decade, becoming one of the fastest-expanding firms in the industry. They now require a
Site Quality Manager
to work on
Galway based Projects.
Key Responsibilities

• Promote a "Right First Time" culture within the project team.
• Address non-conformances (NCRs) by generating quality reports, conducting root cause analysis, and following up on identified issues.
• Inspect and sign off on rework related to non-conformances.
• Ensure project work aligns with Mock Ups and First of Kind specifications.
• Collaborate with site and installation teams to evaluate the effectiveness of quality control procedures.
• Adhere to the company's Project Quality Plan.
• Maintain Inspection and Test Plans (ITPs).
• Oversee the development and execution of Inspection and Test Reports (ITRs).
• Ensure all Quality documentation complies with the Procore platform.
• Follow relevant codes and standards.
• Contribute quality data to project progress reports.
• Manage quality records, acceptance certificates, and project documentation as per requirements.
• Perform BCAR inspections, handle closures, and engage with Assigned Certifiers in meetings.
• Organize handover documentation, including O&M manuals, subcontractor certificates, product details, and as-built drawings.
• Gather necessary product certifications from contractors.
• Participate in site meetings.
• Track and close out compliance issues on projects.
• Ensure adherence to all site safety protocols.

Requirements

• At least 3 years of experience in the construction field.
• A relevant third-level qualification is preferred.
• Experience engaging with clients and site leadership.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office tools such as Word, Excel, PowerPoint, Teams, Outlook, and experience with Procore or similar platforms.

Company Background
Uniphar Group PLC is one of two full line pharmaceutical wholesalers operating in the Irish market. With a turnover expected to be in excess of €1.2billion for 2015, Uniphar is one of Ireland's most successful indigenous companies, managed and run from our headquarters in Citywest, Dublin. The full line wholesaler is the middle man between the Manufacturers and the Pharmacy, who receive in bulk and breaks down and delivers the medicine in average units of 2 across 12,000 products twice daily.

Active right across the pharmaceutical/health supply chain, the Uniphar Group has wholesale depots located in Dublin, Cork, Limerick and Sligo, the company has now built the strongest wholesale depot structure in the Irish market. Our Citywest Distribution Centre (CDC) is a €65M state of the art warehousing and distribution facility and is one of the most technologically advanced of its kind in Europe. This ensures that we offer an excellent distribution service to meet the needs of manufacturers, community pharmacy, hospital pharmacy and veterinary surgery across the country.

Set up 40 years ago by community pharmacists to allow them to control their own supply chain, the roots of the Uniphar Group remain in community pharmacy and ownership is still held largely by community pharmacists. Today Uniphar Group employs approximately 550 people.

In 2013, Uniphar acquired Cahill May Roberts, one of its main competitors, and since then has undertaken a serious investment in IT and infrastructure, including SAP, while integrating the two businesses. Entrepreneurial and fast moving, the company is expected to list on the stock exchange in the next few years.

In 2015 Uniphar continues to grow and has recently acquired Star medical a UK business who provides a full outsourcing and resourcing solution that delivers sales, marketing, medical and clinical people for Pharma, Medical Devices & Technology, Clinical Research and Healthcare Communications businesses; Star's tailored services include dedicated teams, vacancy management, direct to headcount recruitment, consultancy and master vendor. Uniphar also acquired Point of Care Point who is Ireland's leading community specialist healthcare provider. It provides services in the community that allow patients to be cared for in a more comfortable and less costly alternative to hospitalisation.

People & Culture
At the core of Uniphar Group are its people and our employees are the driving force of the business. Uniphar is passionate about hiring and developing high-potential individuals and giving them fast track, long-term careers.

The company hires more than anything on cultural fit and potential to grow within the business. It is a fast moving business in an industry that is going through a lot of change – this means our people have to be adaptable, quick thinking and focused on results.

In order to succeed in Uniphar you will be smart, down to earth, highly commercial and driven. You will need to be flexible in how you think and a strong problem solver. You will also need to be a good leader, able to get the best from your own team and also to work cross functionally and interact effectively with people at all levels of the business.

Role And Responsibilities

• Serve as the designated Responsible Person, ensuring full compliance with ProLuca WDA requirements and all related GxP and Medical Device activities within the On Demand Ireland business unit.
• Act as DRP on Uniphar Wholesale WDA
• Ensure all tasks are executed in alignment with Uniphar Group's policies and procedures.
• Lead and coordinate regulatory and client inspections as necessary.
• Manage and guide the Quality team to achieve strategic and operational objectives.
• Design, implement, and maintain a Quality Management System (QMS) that meets the compliance standards of a Marketing Authorisation Holder (MAH).
• Ensure adherence to quality standards as defined by the QMS.
• Train and support staff in new quality initiatives, promoting understanding and consistent implementation across the site.
• Maintain and update regulatory standards and procedures in line with applicable regulations, guidelines, and specifications.
• Identify opportunities for system improvements or technical issues, collaborating with technical teams to develop and implement effective solutions.
• Oversee outsourced activities for the On Demand business, ensuring robust compliance processes in Pharmacovigilance (PV), Regulatory Affairs, and Advertising, with clearly defined MAH responsibilities in the QMS.
• Act as a Subject Matter Expert (SME) for the management of Exempt Medicinal Products within the On Demand business.
• Evaluate requirements and provide feedback on completeness, risk areas, and potential impacts on quality compliance.
• Collaborate with the wider On Demand Quality and Management Teams to identify and implement process improvements.
• Contribute to the development of high-quality systems that meet documented specifications, compliance standards, and business objectives.
• Lead cross-functional meetings to triage and resolve quality issues.
• Foster strong relationships with internal and external stakeholders, promoting a culture of continuous improvement.
• Prepare and maintain weekly and monthly reports/KPIs summarizing key activities and performance metrics.
• Engage in ongoing professional development and support team learning to stay current with evolving regulations and ensure timely implementation.
• Manage third-party providers and processes related to outsourced GMP activities.
• Undertake additional projects or activities as assigned by the Group Quality Director.

Qualification, Experience & Skills Required

• 3–5 years of professional experience in a regulated environment (GDP, GMP, or Unlicensed Medicines).
• Prior experience working within a commercial affiliate of a Marketing Authorisation Holder (MAH).
• Demonstrated experience in Regulatory Affairs, Pharmacovigilance, and Advertising compliance, specifically related to MAH responsibilities.
• Proven track record of participation in regulatory authority inspections.
• Experience serving as a Responsible Person (RP) or Deputy RP under a Wholesale Distribution Authorisation (WDA).
• Strong leadership capabilities with the ability to manage and develop a small team effectively.
• Excellent interpersonal and communication skills, with the ability to engage confidently across all levels of the organisation.
• Highly developed organisational, analytical, problem-solving, influencing, and management skills.
• Project management experience is advantageous.
• Proficient in standard software applications, including word processing, spreadsheets, and data analysis tools.
• Ability to thrive in a fast-paced, collaborative environment with sound decision-making and problem-solving abilities.
• Strong time management and prioritisation skills, with a focus on meeting tight and overlapping deadlines.
• Exceptional attention to detail, organisational skills, and accuracy in record-keeping.
• Capable of working independently with minimal supervision.
• Familiarity with validation methodologies.
• Commercial awareness and business acumen.
• A bachelor's degree in a science or healthcare is preferred.

COMPETENCIES

• Positive can-do attitude with a focus on action does not debate.
• Results orientated.
• Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met.
• Resolves conflict constructively and works well under pressure.
• Attention to detail.
• Strong communication and negotiation skills.

Company Background

Uniphar Group PLC is one of two full line pharmaceutical wholesalers operating in the Irish market. With a turnover expected to be in excess of €1.2billion for 2015, Uniphar is one of Ireland's most successful indigenous companies, managed and run from our headquarters in Citywest, Dublin. The full line wholesaler is the middle man between the Manufacturers and the Pharmacy, who receive in bulk and breaks down and delivers the medicine in average units of 2 across 12,000 products twice daily.

Active right across the pharmaceutical/health supply chain, the Uniphar Group has wholesale depots located in Dublin, Cork, Limerick and Sligo, the company has now built the strongest wholesale depot structure in the Irish market. Our Citywest Distribution Centre (CDC) is a €65M state of the art warehousing and distribution facility and is one of the most technologically advanced of its kind in Europe. This ensures that we offer an excellent distribution service to meet the needs of manufacturers, community pharmacy, hospital pharmacy and veterinary surgery across the country.

Set up 40 years ago by community pharmacists to allow them to control their own supply chain, the roots of the Uniphar Group remain in community pharmacy and ownership is still held largely by community pharmacists. Today Uniphar Group employs approximately 550 people.

In 2013, Uniphar acquired Cahill May Roberts, one of its main competitors, and since then has undertaken a serious investment in IT and infrastructure, including SAP, while integrating the two businesses. Entrepreneurial and fast moving, the company is expected to list on the stock exchange in the next few years.

In 2015 Uniphar continues to grow and has recently acquired Star medical a UK business who provides a full outsourcing and resourcing solution that delivers sales, marketing, medical and clinical people for Pharma, Medical Devices & Technology, Clinical Research and Healthcare Communications businesses; Star's tailored services include dedicated teams, vacancy management, direct to headcount recruitment, consultancy and master vendor. Uniphar also acquired Point of Care Point who is Ireland's leading community specialist healthcare provider. It provides services in the community that allow patients to be cared for in a more comfortable and less costly alternative to hospitalisation.

People & Culture

At the core of Uniphar Group are its people and our employees are the driving force of the business. Uniphar is passionate about hiring and developing high-potential individuals and giving them fast track, long-term careers.

The company hires more than anything on cultural fit and potential to grow within the business. It is a fast moving business in an industry that is going through a lot of change – this means our people have to be adaptable, quick thinking and focused on results.

In order to succeed in Uniphar you will be smart, down to earth, highly commercial and driven. You will need to be flexible in how you think and a strong problem solver. You will also need to be a good leader, able to get the best from your own team and also to work cross functionally and interact effectively with people at all levels of the business.

Role and Responsibilities

• Serve as the designated Responsible Person, ensuring full compliance with ProLuca WDA requirements and all related GxP and Medical Device activities within the On Demand Ireland business unit.
• Act as DRP on Uniphar Wholesale WDA
• Ensure all tasks are executed in alignment with Uniphar Group's policies and procedures.
• Lead and coordinate regulatory and client inspections as necessary.
• Manage and guide the Quality team to achieve strategic and operational objectives.
• Design, implement, and maintain a Quality Management System (QMS) that meets the compliance standards of a Marketing Authorisation Holder (MAH).
• Ensure adherence to quality standards as defined by the QMS.
• Train and support staff in new quality initiatives, promoting understanding and consistent implementation across the site.
• Maintain and update regulatory standards and procedures in line with applicable regulations, guidelines, and specifications.
• Identify opportunities for system improvements or technical issues, collaborating with technical teams to develop and implement effective solutions.
• Oversee outsourced activities for the On Demand business, ensuring robust compliance processes in Pharmacovigilance (PV), Regulatory Affairs, and Advertising, with clearly defined MAH responsibilities in the QMS.
• Act as a Subject Matter Expert (SME) for the management of Exempt Medicinal Products within the On Demand business.
• Evaluate requirements and provide feedback on completeness, risk areas, and potential impacts on quality compliance.
• Collaborate with the wider On Demand Quality and Management Teams to identify and implement process improvements.
• Contribute to the development of high-quality systems that meet documented specifications, compliance standards, and business objectives.
• Lead cross-functional meetings to triage and resolve quality issues.
• Foster strong relationships with internal and external stakeholders, promoting a culture of continuous improvement.
• Prepare and maintain weekly and monthly reports/KPIs summarizing key activities and performance metrics.
• Engage in ongoing professional development and support team learning to stay current with evolving regulations and ensure timely implementation.
• Manage third-party providers and processes related to outsourced GMP activities.
• Undertake additional projects or activities as assigned by the Group Quality Director.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

• 3–5 years of professional experience in a regulated environment (GDP, GMP, or Unlicensed Medicines).
• Prior experience working within a commercial affiliate of a Marketing Authorisation Holder (MAH).
• Demonstrated experience in Regulatory Affairs, Pharmacovigilance, and Advertising compliance, specifically related to MAH responsibilities.
• Proven track record of participation in regulatory authority inspections.
• Experience serving as a Responsible Person (RP) or Deputy RP under a Wholesale Distribution Authorisation (WDA).
• Strong leadership capabilities with the ability to manage and develop a small team effectively.
• Excellent interpersonal and communication skills, with the ability to engage confidently across all levels of the organisation.
• Highly developed organisational, analytical, problem-solving, influencing, and management skills.
• Project management experience is advantageous.
• Proficient in standard software applications, including word processing, spreadsheets, and data analysis tools.
• Ability to thrive in a fast-paced, collaborative environment with sound decision-making and problem-solving abilities.
• Strong time management and prioritisation skills, with a focus on meeting tight and overlapping deadlines.
• Exceptional attention to detail, organisational skills, and accuracy in record-keeping.
• Capable of working independently with minimal supervision.
• Familiarity with validation methodologies.
• Commercial awareness and business acumen.
• A bachelor's degree in a science or healthcare is preferred.

COMPETENCIES

• Positive can-do attitude with a focus on action does not debate.
• Results orientated.
• Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets met.
• Resolves conflict constructively and works well under pressure.
• Attention to detail.
• Strong communication and negotiation skills.

Job Description
An exciting opportunity to join the Brinny team as Quality Vaccine IPT Lead.
This role will provide Quality leadership to an Integrated Process Team (IPT) to manufacture and supply quality pharmaceutical products with Priorities of Compliance, Supply, Strategy and Profit Plan. Primary focus of position is to ensure straight through product flow and to ensure the team meets all product quality and compliance requirements to enable disposition for each batch. The IPT Quality lead is therefore responsible for providing technical expertise, support and advice to IPT on all Quality Assurance and cGMP compliance aspects. Liaising with QO CoE, supports the IPT in all continuous improvement activities and projects from QA standpoint in spirit of Lean Thinking and Lean Manufacturing. The IPT Quality lead is responsible for supporting Permanent Inspection Readiness and represents Quality Operations to the IPT. The leadership style is one of collaboration, coaching and facilitating the IPT team to a high-performance organisation. This will require a substantial amount of his/her time within the IPT process, engaging and communicating with all IPT members to ensure that the independent voice of Quality is understood and heard throughout the IPT. The IPT Quality Lead is accountable for the Quality oversight within the IPT value stream. This requires the management of a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment. They will be active member within the cross functional IPT Team providing independent quality technical expertise, support and advice to IPT on all Quality Assurance and cGMP compliance aspects.

Primary Activities/responsibilities

• Ensure supply to ensure straight through product flow and to ensure the team meets all product quality and compliance requirements to enable disposition for each batch, through the implementation and oversight of the Quality Management System for the IPT
• Champion the highest Quality and compliance standards for the IPT
• Champion Permanent Inspection Readiness for the IPT
• Lead Quality Team providing ongoing coaching and support to all Quality Team members, including the identification and development of key talent and skills within the team.
• Drive the Quality Team's performance so that every individual understands their individual contribution and how it impacts the site.
• Sound financial stewardship, management and control

Position Specification
Continuous Improvements
Responsible for ensuring that the culture of Continuous Improvement in the Quality Management Systems is based on a solid foundation of compliance and adhering to regulatory requirements by utilising the Six Sigma tools.

Coaching and Training
Develop an effective, focused and strong Quality IPT team by understanding their abilities, unique contribution and broadening their skill set to be agile and prepared for any future business requirements. Provide your team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma) to make them successful. Coach the IPT Leadership team on the required Quality standards and ensure they have full understanding of cGMP requirements.

Key Behaviours
Focus on Customers, Including Patients
Focus the entire organisation on delivering value for customers, including patients, by understanding and meeting their needs.

Collaborate
Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the company.

Act with Candor and Courage
Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions.

Make Rapid, Disciplined Decisions
Make timely decisions at the right level with the right data, and support them once made.

Drive Results
Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results

Demonstrate Ethics & Integrity
Adhere to the highest standards of trustworthy and ethical behaviour in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation.

Build Talent
Build diverse talent with the capabilities necessary to succeed in our markets; inspire, reward and develop to ensure individuals reach their potential; make tough calls when necessary.

Work Experience

• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.).
• At least ten years' experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function.
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation.

Demonstrated leadership and change management skills with a continuous improvement focus.

Qualifications

• Degree or 3rd level qualification (Science, Quality). Desirable Microbiology or biotechnology.
• Desirable QP qualification.
• Evidence of Continuous Professional Development.
• Preference for Lean Six Sigma Green Belt.

Skill Set

• Quality and Process background.
• Proven track record of providing independent Quality expertise to Manufacturing functions.
• Proven track record of delivering high performance through development and coaching of a team.
• Demonstrated ability in holding team members accountable for results and managing performance.
• Demonstrated ability to fully realize improvement initiatives.
• Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
• Advanced PC skills such as Excel, Word, PowerPoint.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status
Regular

Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Not Applicable

Shift
Valid Driving License
Hazardous Material(s)
Required Skills
Achieving Objectives, Achieving Objectives, Adaptability, Biotechnology, CAPA Management, cGMP Regulations, Chemical Manufacturing, Communication, Compliance Analysis, Corrective Action Management, Delivering Value, Deviation Management, Ethical Practices, IS Audit, Laboratory Information Management System (LIMS), Management Process, Microbiology, Molecular Microbiology, People Leadership, Pharmaceutical Management, Quality Control Management, Quality Management System Improvement, Quality Manuals, Quality Risk Management, Quality Standards {+ 5 more}

Preferred Skills
Job Posting End Date
09/18/2025

• A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R

Lead Software Development Engineer in Test

( Java, Automation testing, Spring , Rest Assured, Cypress, API, Jmeter, SQL)

Location:
Dublin, Ireland (Hybrid – 1 day per week onsite)

Contract:
12 months, with potential to extend

We're seeking a hands-on Lead SDET to drive quality across a cutting-edge fraud prevention platform. You'll lead automation strategy, mentor engineers, and champion best practices in test automation, performance, and accessibility testing.

What You'll Do

• Own and evolve test automation strategy, integrating into CI/CD pipelines
• Build and maintain automated tests (Cypress, Java, RestAssured, JMeter, SQL)
• Implement shift-left testing and embed quality from the start
• Lead on performance and accessibility (WCAG) testing
• Collaborate closely with developers and PMs to ensure high-quality delivery
• Mentor engineers and uplift testing practices across the team

What You'll Bring

• 9+ years in test automation and software quality engineering
• Strong Java and Spring development skills
• Expertise with Cypress (UI) and RestAssured (API)
• Experience in performance testing (JMeter) and SQL
• Proven ability to lead automation strategy and coach teams
• Strong communication, problem-solving, and leadership skills

Quality Assurance Lead – ERP Implementation Project

Description

A highly experienced and detail-oriented
Quality Assurance Lead
is required for an
ERP Implementation Project
. This role involves leading the quality and compliance aspects of an SAP Cloud ERP transformation. It is a critical position for ensuring GxP compliance, data integrity, and operational excellence across regulated pharmaceutical operations.

Location:
Onsite in QC Laboratory, Loughrea, Co. Galway.

Key Responsibilities

• Define and implement the QA strategy for SAP ERP in line with regulatory and operational requirements.
• Establish and enforce quality governance frameworks, policies, and procedures.
• Lead the QA workstream within the SAP S/4HANA Cloud ERP programme, following an "Adopt not Adapt" methodology.
• Collaborate with SAP consultants, business stakeholders, and technical teams to embed quality requirements into system design and configuration.
• Ensure compliance with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11.
• Support the Computer System Validation (CSV) lead and coordinate with external vendors.
• Review and approve project documentation.
• Implement audit trails, electronic signatures, and access controls to guarantee inspection readiness and data integrity.
• Act as the main liaison between stakeholders and project teams on all quality-related matters.
• Facilitate workshops and training sessions to strengthen compliance culture.
• Monitor quality KPIs and drive continuous improvement initiatives.
• Provide quality insights to manufacturing, supply chain, and regulatory teams to optimise operations.

Skills & Competencies

• In-depth knowledge of SAP S/4HANA or SAP Cloud ERP in regulated pharma or CDMO environments.
• Practical experience with:
• Quality Management (QM) module
• Batch management and traceability
• Inspection planning and execution
• Integration with LIMS and EQMS
• Familiarity with SAP Best Practices and Fit-to-Standard methodology.
• Strong understanding of GDP, GxP, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
• Experience supporting CSV activities and audit readiness.
• Proven leadership of QA workstreams in large-scale ERP implementations.
• Proficiency with SAP Signavio or similar tools for process modelling and validation traceability.
• Strong leadership, communication, and stakeholder management skills.

Qualifications & Experience

• 5+ years of Quality Assurance experience in regulated pharmaceutical or CDMO environments.
• Extensive ERP implementation experience with a strong focus on SAP systems.
• Demonstrated leadership in CSV and QA-driven ERP projects.
• Familiarity with tools such as SAP Signavio for process modelling and validation traceability.
• Experience with AI/ML tools for quality monitoring and validation (desirable).