18 Management jobs in Sligo

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a Lab Compliance Manager to join our team on our Manorhamilton Road site in Sligo. The Lab Compliance Manager drives project-related activities within the QC department, focusing on the introduction of innovative analytical techniques, automation, and the transition to a paperless lab environment. This role is pivotal in the implementation of the "Lab of the Future" concept and managing lab expansion projects.
Responsibilities:
+ Lead and manage all project-related activities in the QC department.
+ Oversee the introduction of new analytical techniques, focusing on automation and paperless laboratory systems.
+ Manage the implementation of the Lab of the Future initiative in the QC department.
+ Coordinate and oversee laboratory expansion projects.
+ Manage and oversee compendial reviews, documentation control for QC, maintenance and calibration of analytical instrumentation, analytical work orders on maximo and retain management.
+ Manage purchasing and budget control, including vendor managed inventory, laboratory cleaning services and capital requirements for QC.
+ Manage and ensure delivery of training curricula for QC via laboratory trainer role.
+ Lead operational excellence in QC delivering on various initiatives including reduced testing program for QC.
+ Liaise with PDS&T to ensure execution of reference standard interval testing program.
+ Lead inspection readiness in QC. Participate in internal and external audits and address audit findings.
+ Ensure compliance with data integrity policies and regulatory requirements.
+ Liaise with cross-functional teams to facilitate project goals and timelines.
+ Present project updates and technical data to stakeholders effectively.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Experience working in API and OSD QC laboratories.
+ Minimum 4 years of experience in people management within a QC lab setting.
+ Strong project management, presentation, and communication skills.
+ Innovative thinking, with a commitment to advancing laboratory practices and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

**FIXED TERM CONTRACT**
**Abbott in Ireland**
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, Longford, and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations, and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
**Abbott Nutrition**
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® - to help get the nutrients they need to live their healthiest life.
**PURPOSE OF THE JOB**
As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, the candidate will use his/her in-depth understanding of medical devices to ensure compliance with regulatory requirements for Abbott Nutrition medical devices. The MSS Global Medical Device Manager will have responsibility for generating documentation that supports Abbott Nutrition's global medical device registration and on-going compliance with EUMDR. This may include development and implementation of global standardized operating procedures. The candidate may also lead the development/maintenance of local medical device vigilance systems (predominantly for UK and EU), ensuring compliance with local regulations. The candidate will have departmental, cross functional, and global influence, and will be considered a medical device subject matter expert within the company.
**MAJOR RESPONSIBILITIES**
+ Organizes, manages and maintains a highly compliant global medical device system for Abbott Nutrition.
+ Maintains awareness and ensures compliance with established and updated local and global medical device processes as well as local and global regulations and guidelines for medical device registration and post-market documentation.
+ Develops and implements training programs for individuals involved in medical device activities.
+ Monitors medical device system performance; tracks compliance metrics and reports to global MSS Leadership Team.
+ Ensures global/local medical device audit readiness; Supports medical device audits/inspections and leads activities related to corrective and preventative actions for any audit findings.
+ Actively contributes to activities related to the monitoring of safety profiles for Abbott Nutrition products registered as medical devices, such as signal detection, evaluation, and prioritization.
+ Reviews and provides input to product DFMEAs.
+ Assists local staff with drafting and implementation of Safety Data Exchange Agreements, if applicable.
+ Works cross-functionally with Regulatory Affairs and Quality Assurance functions to maintain current knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into practices and procedures.
+ Assists in the preparation, review and submission of aggregate safety reports.
+ Accountable for strategic preparation of medical device regulatory submission documentation (i.e. CEP, CER, PSUR, PMCF etc) and on-time completion of these activities for the division.
**EDUCATION & COMPETENCIES**
+ Master's degree in related health science or equivalent skills, education, or experience.
+ RAC certification is a plus.
+ 5-7 years of experience and proficiency in medical device regulatory submissions to Notified Bodies under EUMDR / MedDEV and knowledge of Medical Device standards and guidelines (such as ISO, GSPR, and MDGC).
+ Solid understanding and working knowledge of medical device regulatory requirements and in the development and implementation of processes to maintain compliance.
+ Strong medical knowledge and understanding to support safety related activities; background/experience with nutrition/nutritional products is a plus.
+ Knowledge of Vigilance reporting regulations on a Global scale.
+ Minimum 3 years of experience in leading complex projects or programs; global/regional experience desirable.
+ Fluency in spoken/written English;
+ Computer proficient (Windows, Word, Excel); experience working in adverse event databases.
+ Excellent communication and interpersonal skills, both written and spoken.
+ Strong organizational skills with proven ability to prioritize and work on multiple tasks and projects.
+ Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.
+ High level of accountability and reliability.
+ Demonstrates ability to work productively as a team.
+ Ability to work in a fast paced, changing environment.
+ Ease of operating in high stress, big decision situations.
+ Continuous improvement mindset.
+ Ability to influence a team in a positive way in relation to performance, change, and culture.
+ Demonstrate broad knowledge of Abbott's business and how department processes/responsibilities interconnect.
+ Mastery of the inventory deployment planning process.
+ Exceptional problem-solving skills
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are seeking a highly motivated and experienced Operations Shift Supervisor to join our Drug Product Pharmaceutical manufacturing team. In this key leadership role, you will oversee the safe and compliant production of drug product materials, ensuring all operations meet regulatory, safety, and organizational standards.
You will lead a team of pharmaceutical technicians, drive continuous improvement, and play a crucial part in maintaining AbbVie's reputation for quality and excellence.
Key Responsibilities:
+ Supervise and execute pharmaceutical processing activities to meet operational objectives.
+ Lead, motivate, and develop a team of 10-12 direct reports, ensuring clear communication of tasks and goals.
+ Plan resources and coordinate training to ensure safe and efficient operations.
+ Measure, report, and own key departmental performance metrics (yield, rate, usage, attendance, overtime, etc.).
+ Ensure compliance with all safety, environmental, and quality SOPs.
+ Collaborate with other shift supervisors and internal/external stakeholders to ensure smooth interdepartmental operations.
+ Manage employee relations, performance reviews, and growth plans in partnership with HR.
+ Maintain accurate personnel records and update manufacturing control systems.
+ Support and implement key site and departmental strategies.
+ Adhere to all EHS & E (Environment, Health, Safety & Environment) standards and policies.
+ Lead and participate in continuous improvement initiatives.
+ Represent your area during regulatory inspections and audits.
Supervision & Leadership:
+ Operate with a high degree of autonomy, reporting to the DP Operations Leader.
+ Set annual goals, conduct performance reviews, and manage team development.
+ Act as a site Subject Matter Expert (SME) for DP Manufacturing issues.
+ Provide technical leadership and collaborate with key stakeholders.
Qualifications
+ Diploma in a relevant science or engineering discipline, or equivalent experience.
+ Minimum 3 years' experience in batch processing operations within an FDA/HPRA regulated pharmaceutical environment.
+ Detailed knowledge of cGMP and regulatory requirements.
+ At least 3 years' experience in a highly automated environment.
+ Minimum 3 years' direct supervisory experience or relevant training.
+ Proven experience leading teams and participating in improvement programs.
Skills & Attributes:
+ High attention to detail and commitment to compliance.
+ Innovative thinker with strong problem-solving skills.
+ Results-driven, with the ability to prioritize and meet business demands.
+ Strong verbal and written communication skills.
+ Excellent interpersonal and leadership abilities.
+ Demonstrates integrity, a strong work ethic, and a "Right First Time" mindset.
+ Flexible to meet business needs, including shift work.
Additional Information
Why AbbVie? Join a global leader in the pharmaceutical industry, where you'll have the opportunity to make a real impact, develop your career, and work with a passionate team dedicated to improving lives.
How to Apply: If you are ready to take the next step in your career and lead a high-performing team in a world-class manufacturing environment, we want to hear from you!
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
AbbVie Ballytivnan is a Centre of Excellence for Precision High Volume Moulding and Auto-Assembly, and is a state-of-the-art Biologics aseptic fill finish facility.
We are looking for an ADC Technical Manager to provide technical support and day-to-day program management to all new product introductions (NPIs) sitewide across 3 departments which will include ADC conjugation, BT1 and ADCBT2. The position is based in Sligo and report the Technical Operations Manager. The successful candidate will provide team leadership to the NPI product team, process team and ADC team. This is an exciting time to join the team as we continue to introduce new products and innovation.
Roles and Responsibilities
+ Lead and support NPI activities for product, processes and technology from early-stage development through to PPQ.
+ Lead and manage cross functional teams across different skillsets and disciplines to perform activities required to deliver NPI's.
+ Collaborate with cross functional teams including Process Development, Science & Technology (PDS&T), Quality, Manufacturing, Supply Chain and ECM to facilitate the smooth transition of new products from development to commercialization.
+ Complete all site fit assessments for all the products from AbbVie pipeline and ECM opportunities
+ Provide technical direction and oversight and coordinate support for NPI activities across the entire biological manufacturing area
+ Work closely with internal and external program management to ensure alignment on NPI schedules
+ Ensure resource availability for all NPI related activities
+ Build and maintain a mindset of innovation and continuous improvement withing the function.
+ Provide leadership and mentoring for operations personnel during NPI activities
+ Collaborate with external parties to ensure engagement and alignment and open communication throughout NPI activities
+ Engage with external and internal partners to influence the design and implementation of robust process control strategies on process risk assessments
+ Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the application product transfer stage gate review
+ provide technical input, review approval for documentation associated with NPI activities
+ Ensure ongoing compliance with CGMP and EHS practices new
+ Participate in NPI project gate reviews
+ Interface with internal auditors and outside regulatory agencies auditors as the subject matter expert for new products and technology transfers
Qualifications
+ Ph.D in Chemistry, Biochemistry, Chemical Engineering or related field
+ Minimum 10 years experience in pharmaceutical or biotechnology industry
+ Proven strategic leadership experience with the ability to inspire and motivate a diverse and global team. Extensive experience from working in an international organisation and across borders.
+ Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC technical lifecycle management
+ In-depth understanding of regulatory and quality requirements in relevant area.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
We are looking for a QC Manager to join our team on our Manorhamilton Road site in Sligo. The QC Lab Manager is integral to managing a team responsible for QC testing, ensuring adherence to product specifications, quality, and safety goals. This role involves overseeing laboratory operations, including analytical testing for API and OSD products, and coordinating with internal teams to meet testing schedules.
Responsibilities:
+ Manage a lab team performing QC testing, ensuring compliance with data integrity policies and regulatory requirements.
+ Conduct and supervise all aspects of API and OSD analytical testing.
+ Ensure timely sampling, inspection, and testing, coordinating with teams for schedules and priorities.
+ Participate in internal and external audits and address audit findings.
+ Prepare technical reports, lead investigations, and implement CAPAs.
+ Provide training and support to lab team to achieve daily and long-term goals.
+ Present technical data to stakeholders to facilitate prompt decision-making.
+ Report to the Senior QC Manager.
Qualifications
+ M.Sc./B.Sc. in Chemistry or a related discipline.
+ Minimum 4 years of experience in people management within a pharmaceutical lab setting.
+ Strong knowledge of QA/QC operations, analytical testing for API and OSD.
+ Excellent presentation and technical report writing skills.
+ Strong communication and interpersonal skills, with a commitment to quality and compliance.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
*Please note that job level/grading my differ from country to country*
Purpose
Manage a team of Manufacturing Professionals responsible for Third Party Manufacture (TPM) contracts for Medical Devices or Combination Products. Assure that high quality products are manufactured in compliance with local and international regulations, and released and delivered according to the established forecasts, schedules, and cost planned. On going monitoring quality and delivery performance while minimizing risks associated with outsourcing production to a Third-Party Manufacturer.
Responsibilities
+ Lead a team of AbbVie TPM Account Managers to: Negotiate and manage Manufacturing Service Agreements (MSA), contract Amendments, and updates as needed, while ensuring compliance with the terms of the agreements. Asure global logistics are in place to support all phases of the manufacturing agreement in accordance with Purchasing and Supplier Quality expectations.
+ Lead the development of ECM Device Financial Operating Plan, Updates, LRP, and Standard processes, and assure the financial goals are met. Monitor and control manufacturing costs to ensure efficient use of resources while maintaining product quality.
+ Ensure timely communication with TPM in all aspects of the product agreement including product forecasts, manufacturing and delivery schedules. Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery.
+ Monitor manufacturing performance; apply OPEX (Operational Excellence) metrics as appropriate and ensure TPM manufacturing processes and standards align to deliver product in accordance with AbbVie quality & performance expectations.
+ Assure in coordination with internal AbbVie functional partners that the TPM has the required quality systems and documentation to meet regulatory requirements, follow up inspection responses and commitments. Coordinate with PQA, the annual quality management review and periodic audits of the TPM. Assure deviations are properly investigated and product disposition decisions are made in a timely manner.
+ Coordinate routine management reviews and provide on-going communication informing internal and TPM stakeholders of performance against expectations, highlighting issues, actions, and on-going improvements to increase performance at TPMs.
+ Identifying and Selection of Third-Party Manufacturers (TPM); ensure team engagement on cross functional evaluation of new product needs and TPM's due diligence initiatives.
+ Identify, evaluate, and maintain strong relationships with third-party manufacturers to ensure quality production and timely delivery from onboarding, contract negotiations though renewals of the TPM.
+ Identify potential disruptions like geopolitical instability, natural disasters, or labor issues and develop mitigation strategies.
+ Ensure the manufacturer adheres to all relevant regulations regarding safety, environmental standards, and labor practices.
+ Foster a collaborative partnership with TPMs to ensure mutual understanding and commitment to quality & performance.
+ Lead a performance improvement culture & programs across TPMs; guide Account Managers to anticipate and act on ideas to increase efficiency and effectiveness.
+ Establish and manage clear team expectations regarding roles & responsibilities, G&O's while champion and model AbbVie's performance and talent management practices.
+ Develop and manage staff through hiring, managing performance, developing talent and providing clear expectations.
Qualifications
Qualifications
+ Bachelor's Degree required in a technical field: advanced technical degree (Master's or Doctorate Degree) strongly
preferred.
+ 15+ years' experience including: manufacturing of Medical or Electro-Mechanical Devices
+ Strong technical and manufacturing assembly management experience
+ Progressively increased responsibility and performance as supervisor, department manager and leader in Operations (Manufacturing, Quality, Engineering, etc.) Proven ability to inclusively manage and develop teams.
+ Strong communication skills, ability to build trust and rapport, clear goal setting, fostering collaboration, promoting creativity, and adapting leadership style to suit the team's needs.
+ Business acumen coupled with functional leadership experience is required to ensure effectiveness and high performance in a complex operation.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.
+ This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Title: Business Excellence Site Head
At our AbbVie Manorhamilton Road site in Sligo innovation is at the heart of everything we do. The Business Excellence Site Head position is pivotal in executing the overall Business & Operational Excellence strategy for the site, encompassing PMO (Project Management Office) and Operational Excellence (OpEx). In this role you will collaborate with all departments to spearhead new and innovative processes that drive cost improvements and process optimization, aligning efforts with AbbVie's global standards.
This is a key position for our site and will give you the opportunity to influence the site's growth and strategy as well as making an impact across multiple teams within the operation. You will be part of the SLT and have a dedicated team of Op Ex and PMO professionals reporting into the role.
The site is situated in the beautiful surrounds of Sligo and can offer you a defined career path, comprehensive benefits and a supportive environment that promotes a positive work life balance.
If you are interested in starting a conversation with AbbVie MHR Sligo then read on for more information and start your application today!
Responsibilities:
+ Leadership: Lead the OpEx and PMO teams, providing strategic direction and oversight.
+ Project Management: Execute key strategic projects on-site, manage the overall project portfolio, and ensure alignment with business goals and priorities.
+ Compliance: Ensure the department's adherence to regulatory, safety, and environmental compliance, conforming to AbbVie Global policies.
+ Goal Setting: Collaborate with the Site Director to set departmental goals, schedules, and timetables.
+ Performance Metrics: Control and report critical performance metrics and oversee departmental budgets.
+ Team Leadership and Development: Leading program and project managers to maximize personnel potential through career development planning and foster a culture of open communication and teamwork.
+ Strategic Partnerships: Build and maintain strategic partnerships with internal and external executive-level management, regulatory agencies, vendors, and suppliers.
+ Continuous Improvement: Cultivate a culture of continuous improvement in business processes and personnel development.
+ Tools Implementation: Support the implementation of Business Excellence tools to drive ongoing improvement initiatives.
Qualifications
Education and Experience Required:
+ A bachelor's degree in a relevant Science, Engineering, or Business Discipline.
+ 10 years of experience in the Pharmaceutical Manufacturing industry, with managerial experience and experience in executing strategic business projects.
+ In-depth knowledge of Manufacturing, Supply Chain, R&D, S&T, and CMO organizations.
+ 5 years of demonstrated project management skills, ensuring projects are delivered on schedule, within budget, and meet defined quality standards.
+ Over 2 years of direct people management experience at a management level.
AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The Quality Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. This role serves as the Person Responsible for Regulatory Compliance for the EU Authorized Representative under EU MDR 2017/745, providing compliance subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Ideally, this person will be based near one of our sites that manufacture medical devices in Ireland, either in Sligo or Westport.
Responsibilities:
+ Serve as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative, fulfilling all in-country obligations under EU MDR 2017/745.
+ Host external audits in the EU region, demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other country-specific device audits.
+ Conduct internal audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
+ Lead root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
+ Maintain expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
+ Perform regulatory compliance assessments of high complexity to support decision-making in critical business decisions, including Market Actions.
+ Analyze and interpret quality system performance metrics, presenting to Top Management as part of Management Reviews.
+ Program-manage initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications
+ Bachelor's degree, preferably in engineering, physical science (e.g., Chemistry), life science (e.g., Microbiology or Biology), or pharmacy and a minimum of 7 years of industry experience in a GXP regulated environment.
+ ISO 13485 Lead Auditor certification by a professional body is preferred. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
+ Operates with a high degree of autonomy and accountability, making independent quality and compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time. The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
This is a hybrid role with 3 days on site, 2 days remote.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Are you passionate about hospitality and driven by excellence? Our 4-star hotel client in Co. Sligo is seeking an experienced and motivated Food & Beverage Manager to lead the team and ensure the highest standards of service across all food and beverage outlets. *** Initial assistance with accommodation and guidance for securing long-term accommodation*** The Role: As Food & Beverage Manager, you will take full responsibility for the day-to-day operations of the hotels bars, restaurant, banqueting, and events. You will lead by example, driving exceptional service delivery, implementing and maintaining high standards, and fostering a culture of continuous improvement. Key Responsibilities: Oversee the smooth and efficient running of all food and beverage outlets. Drive and maintain consistently high standards of service and product quality. Lead, motivate, and develop a strong F&B team with a focus on training and performance. Manage costs and budgets effectively while maximising revenue opportunities. Ensure compliance with health, safety, and hygiene standards at all times. Collaborate with senior management to enhance the overall guest experience. The Ideal Candidate: Previous experience as a Food & Beverage Manager in a 4* or similar high-standard environment. Strong leadership and people management skills. A proven ability to deliver and maintain exceptional guest service standards. Excellent organisational, communication skills. A hands-on manager with a passion for hospitality and continuous improvement. What We Offer: Competitive salary. Initial assistance with accommodation and guidance for securing long-term accommodation. Opportunity to work in a well-regarded 4* property in scenic Sligo. Supportive management team and opportunities for career progression. If you are standards-driven, guest-focused, and ready to make a real impact, wed love to hear from you, please submit your updated CV to Karen's attention through the link provided Skills: Food & Beverage Hospitality Standards Hands on