AbbVie CMC QA Validation Lead, Europe in Dublin, Ireland

CMC QA Validation Lead, Europe

Ireland, Leinster, Dublin

4 additional locations

Ireland, Connaught, SligoGermany, Rhinland-Palatinate, LudwigshafenIreland, Munster, CorkItaly, Lazio, Campoverde

Quality Assurance

Requisition #1805045

AbbVie employees work every day to discover and address many of the world's most pressing health challenges. Our work helps people live better lives. When you have patients depending on your solutions, you look for the best people to be part of the team. We are always looking for talented people to join our team and, when we find them, we make it our business to treat them well.

We are currently sourcing a CMC QA EU Validation Lead to coordinate the development and maintenance of the company’s validation program in compliance with all applicable regulatory and AbbVie requirements to ensure flawless New Product Introduction PPQ execution across the network operations manufacturing sites. In this role, you will lead communication planning, preparation and actions to ensure improvements are harmonized and shared across the manufacturing network and the quality system documents and IT systems are aligned accordingly.

This is an exciting new role that can be based in Ireland (Santry, Sligo or Cork), Germany or Italy!

Key Responsibilities:

  • You will develop and implement global strategic initiatives to ensure New Product Introduction PPQ’s are executed RFT, including:

  • You will co-ordinate the direction of the qualification of site equipment, facilities, utilities, processes, cleaning and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards to ensure they meet the requirements for NPI’s.

  • Collaborating with partners including Global and Site Operations and QA, Science & Technology and Research & Development to drive broader network efficiency will be a key element of this role

  • You will review/approve Project Validation Plans associated with New Product Introductions. in addition to ensuring validation protocols and final reports associated with New Product Introductions is to cGMP standard

  • Review / Approval and Oversight of validation change control processes across all sites with New Product Introductions

  • You will lead process improvement initiatives identified while developing and monitoring leading indicators of validation execution performance.

  • As a result, you will develop actionable resolution plans where needed

Education & Experience:

  • 3rd level qualification in engineering or scientific discipline.

  • A minimum of 10 years experience in a cGMP regulated environment, with validation activities demonstrated successfully.

  • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.

  • Requires proven problem solving skills and the ability to adapt to new requirements.

  • Is results driven striving to meet all targets and standards.

  • Strong communication skills both verbal and written are required for the execution of this role.

  • Strong interpersonal skills are required.

  • This position is crucial in identifying validation requirements and developing actionable plans for successfully delivery across the network.

  • Ensures all procedures/policies and guidelines are adhered to.

  • Is a Global SME on all Process Validation issues and provides guidance on same.

  • Provide technical leadership to the AbbVie network and collaborates with key site stakeholders.

  • Responsible for the presentation of technical data to stakeholders to ensure prompt decisions.

Travel:

25% Travel