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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Product QA Manager

Sligo, Connaught, Ireland Req ID 2210592 Category Quality Assurance Division AbbVie

Want to make a global impact? We offer that.

Want to be part of a Great Place to Work in Ireland? We offer that too.

Welcome to AbbVie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are now recruiting for a Senior Product QA Manager for our Manorhamilton Road site in Sligo. This person will lead the Site Product QA group. They will ensure that products manufactured meet requirements of end users, Regulatory Authorities and the company. You will also be expected to ensure products   are manufactured in accordance with the relevant marketing authorisation & GMPs. The Senior Manager, Product QA is responsible for ensuring that all products (commercial and NPI (CTS)) produced at AbbVie Ireland NL B.V. are manufactured in compliance with the applicable GMPs, the site and AbbVie Quality Systems.

Are you intrigued? Do want to learn more?

A snapshot of your key responsibilities as Senior Product QA Manager would be:

  • Managing the QP Team, Regulatory SME and Quality Specialist Teams including batch review & release, product performance, new products introduction (NPI), regulatory support, change management, and customer complaint management. 
  • Ensuring that products manufactured at AbbVie Ireland NL B.V. meet requirements of end users, Regulatory Authorities and of the company.
  • Ensure the principal manufacturing and testing processes have been validated; account has been taken of the actual production conditions and manufacturing records.
  • Ensure any deviations or planned changes in production or quality control have been authorised by the persons responsible in accordance with a defined system. Any changes requiring variation to the marketing or manufacturing authorisation have been notified to and authorised by the relevant authority.
  • Troubleshooting and the effective resolution of issues (deviations)
  • Should maintain their knowledge and experience up to date in the light of technical and scientific progress and changes in quality management relevant to the products they are required to certify.
  • Support all site NPI activities including QMP & change plan review, validation, MIR / recipe and documentation review & approval, review of executed manufactured CTS batches and release of CTS batches. 
  • Management and execution of regulatory requests to support AbbVie Global CMC and RA, review of dossiers for submission / questions received. 
  • Management of the Change management process including review of change plans, chair of CRB, QP review & approval of CPs, QA Specialist review & approval of CP tasks. 
  • Management of Product Quality Review Process including review & approval of all PQRs. 
  • Management of site track and trend process for finished product (API & DP) data. 
  • Supports the principles of Perfect Performance
  • Leads the Site Product QA group
  • Provide technical leadership to functional areas and collaborates with key stakeholders

So, what do you need to do this role?

  • Third level qualification in a science discipline with minimum 5 years’ experience in the healthcare/pharmaceutical industry.
  • MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Minimum 5 years industrial experience gained in an FDA and EMA approved pharmaceutical environment.

So, are you ready to join our team?

It’s important to remember, 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.

Travel: No
Job Type: Experienced
Schedule: Full-time

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