Senior NPI Compliance Specialist
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Sligo, SO
- Operations
- On-Site
- Full-time
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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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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https://www.abbvie.com/join-us/reasonable-accommodations.html
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Pay Range: $
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Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.