Senior NPI Compliance Specialist

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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 hiring a Senior NPI Compliance Specialist to join our NPI QA team at the Ballytivnan site. This role is responsible for ensuring that all new products introduced to the site meet the requirements of GMP, end users, Regulatory Authorities, and AbbVie standards. The Senior NPI Compliance Specialist will be responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross-functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.

What you will do:

• Be responsible for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.
• Support review and approval of NPI related Analytical Test Method Transfers and/or validation.
• Collaborate with CMC QA, R&D, S&T, clients and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
• Coordination of site review of new product related material specification documents including but not limited to in process, BDS, Drug Product, raw material and excipient specifications.
• Support the management of new product related exception documentation, including the generation of corrective and preventative action to prevent reoccurrence.
• Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.
• Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
• Adheres to and supports all EHS & E standards, procedures and policies.
• Serve as a designee for the NPI Compliance Lead as required.

What you will need:

• Minimum of 5 years’ experience in the healthcare, pharmaceutical, or biopharmaceutical industry 
• A third level qualification in a science, quality or relevant field
• At least 2 years experience gained within an aseptic processing environment, ideally within a quality function 
• High level of expertise in day-to-day quality and compliance decision-making 
• In-depth knowledge of GMP requirements and regulatory frameworks 
• Strong attention to detail and commitment to compliance and quality standards 
• Ability to facilitate quality decision-making while maintaining a strong patient focus and upholding AbbVie’s reputation 

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. 

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