2 Diagnostics jobs in Ireland

Supplier Quality Leader, Pharmaceutical Diagnostics

Cork, Munster GE HealthCare

Posted 8 days ago

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Job Description

**Job Description Summary**
In this Global Pharmaceutical role, you'll be responsible for maintaining quality oversight for suppliers and service providers utilized by the GE HealthCare Pharmaceutical Diagnostic (PDx) manufacturing sites. Develop, monitor and maintain positive relationships with external partners and sites to encourage strong collaboration, continuous improvement, transparency and accountability. Ensure products meet or exceed GE Healthcare quality, safety and regulatory requirements.
**Job Description**
**Responsibilities**
+ Complete supplier qualification activities for both existing and prospective external suppliers.
+ Act as a single point of contact for all quality related activities at external suppliers.
+ Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc)
+ Assure Corrective and Preventive Action plans are developed and executed appropriately.
+ Responsible to develop and maintain Quality Agreements between GE Healthcare and external suppliers.
+ Responsible for the coordination and completion of audits, participating in and/or leading audits.
+ Ensure Change Controls, initiated by supplier or by GE Healthcare are managed appropriately.
+ Assist in Health Authority inspection preparations and providing support throughout as required.
+ Track and trend key quality indicators / metrics to monitor supplier and QMS performance.
+ Assure suppliers comply with all GE Healthcare QMS, procedures and regulatory requirements.
+ Develop positive relationships with all internal partners, i.e. Sites, Sourcing, Supply Chain etc
+ Provide quality support for New Product Introductions and transfers project activities.
+ Interact with Suppliers, Sites and Sourcing to drive improvements to minimize costs of quality.
+ All other duties as assigned by manager
**Qualifications and Requirements:**
+ Bachelors Degree in Science discipline (or non-technical degree with significant experience in manufacturing, engineering or equivalent knowledge or experience or quality assurance experience, or an Associate's Degree with major manufacturing, engineering, or quality assurance experience) or equivalent knowledge or experience.
+ Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
+ Proficiency with Microsoft Excel spreadsheet development and analysis.
+ Extensive experience conducting supplier auditsin a regulated environment.
+ Deep knowledge of global regulationssuch as GMP, FDA, ISO 9001, and other relevant standards.
+ Proven success in negotiating and managing Quality Agreementswith external partners.
+ Strong communication and relationship-building skills to influence and collaborate across global teams.
**?** **Desired skills:**
+ Ability to effectively communicate within all levels of the organization
+ Demonstrated collaboration, negotiation & conflict resolution skills.
+ Excellent oral communication & report-writing skills in both.
+ Ability to work within a matrix organisation across different cultures
Inclusion and Diversity
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-BG1
#LI-onsite
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.

Quality Technical Product Manager, Pharmaceutical Diagnostics

Cork, Munster GE HealthCare

Posted 8 days ago

Job Viewed

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Job Description

**Job Description Summary**
Are you ready to make a significant impact in the world of Pharmaceutical Diagnostics (PDx). Join our dynamic IT team as a Quality Technical Product Manager!
In this pivotal role, you will collaborate closely with our Quality colleagues to shape strategic digitization priorities, develop a robust portfolio of investments, and create compelling business cases. Your expertise will be crucial in crafting detailed business requirements for approved investments and overseeing the delivery of key projects and products, including LIMS, Chromatography systems, Environmental Monitoring system, Quality Management system. This role ensures that all Quality IT systems are compliant with regulatory guidelines and drive continuous improvement in Quality processes.
You will help implement technology solutions in a cost-effective way by determining the requirements of a project or program, in alignment with strategic roadmap that helps achieve business objectives.
**Job Description**
**Responsibilities**
+ Implement, and maintain IT systems and software for the Quality department to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).
+ Manage the investigation and resolution of IT-related issues, including system non-conformances and deviations. Lead investigation and troubleshooting on critical Lab application issues, and coordinate with different teams to get desired results.
+ Adept at requirements gathering & analysis through leading business process review sessions and stakeholder interviews.
+ Translate unstructured or ambiguous requests into actionable requirements through problem decomposition and planning.
+ Ability to map As-Is process based on inputs from business SME's and help establish the future process state
+ Prioritize continuously in accordance with the understanding and validation of customer problems and needs.
+ Stay updated with industry trends and regulatory changes to ensure compliance and best practices.
+ Lead the implementation of new IT technologies and methodologies to enhance QC efficiency and accuracy.
+ Own the short-term product roadmap and its integration into a larger application or strategic roadmap.
+ Strong written and verbal communication skills.
+ Function as communication hub for business to collate requirements and coordinate & drive deliverables.
+ Demonstrates strong analytical and creative problem solving and prioritisation skills
+ Demonstrate practical experience in Business Analysis methodologies to run meetings & stand-ups, relevant project documentation, and change controls to collaborate with all stakeholders.
**Qualifications and Requirements**
+ A Bachelor's Degree in Computer Science or "STEM" Majors (Science, Technology, Engineering and Math) or equivalent
+ Strong relevant professional experience in working in the Pharma or IT Industry including experience in the Digital Lab domain
+ Technical experience with Quality platforms such as, but not limited to - LIMS (Lab Information Management System), Chromatography systems (Chromeleon, Empower) , Environmental Monitoring, Quality Management systems is Mandatory.
+ Expert understanding of analysis & design and system architecture concepts.
+ Expert knowledge of CSV lifecycle with understanding of GxP (GLP/GCP/GMP), 21CFR Part 11, EU Annex 11.
+ Ability to execute in a technical environment and willingness to engage and understand technical solutions, challenges and issues.
+ Expert understanding of the Lab business processes, drug development experience an advantage
+ Ability to break down problems, build requirements for development tasks in an agile manner.
**Desired Characteristics:**
+ Experience with Cloud technologies, Java, JavaScript, JBoss, SQL, Windows Server, Citrix, Integrations
+ Experience working in remote / global teams.
+ Entrepreneurial mindset - champions new technology, predicts trends, and identifies new opportunities based on trends. Ability to make technology choices based on experience and willingness to take calculated risks and experiment with newer technologies.
+ Ability to develop partnership with stakeholders and develop an inclusive & collaborative environment.
+ Ability to effectively present portfolio, project plans, technical roadmaps, risks and recommendations to senior business leaders
+ Certifications such as CSBA, CBAP, or PMP
**Leadership:**
+ Pre-emptively sees downstream consequences and effectively tailors influencing strategy to support a positive outcome.
+ Able to verbalize what is behind decisions and downstream implications. Continuously reflecting on success and failures to improve performance and decision-making.
+ Understands when change is needed. Participates in technical strategy planning.
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-BG1
#LI-onsite
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
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