We are hiring a Quality Assurance Manager to lead our QA team at the Ballytivnan site. This role is responsible for ensuring that all products manufactured at AbbVie meet the requirements of GMP, end users, Regulatory Authorities, and AbbVie standards. The Quality Assurance Manager will oversee team performance, compliance activities, audits/inspections, and serve as a critical partner to operational functions to maintain and improve quality across the site.
Key Responsibilities:
- Ensure products manufactured at AbbVie meet requirements of end users, Regulatory Authorities, and AbbVie.
- Lead and manage the Quality Assurance team, providing guidance and support on quality and compliance matters.
- Act as a site contact for regulatory and customer audits/inspections (FDA, HPRA, etc.) and prepare site teams for successful outcomes.
- Manage CAPA (Corrective and Preventive Action) implementation, and follow-up activities.
- Collaborate cross-functionally to resolve quality issues, improve processes, and ensure continuous compliance with cGMP and other relevant regulations.
- Promote department goals by attracting, developing, and retaining capable QA staff.
- Contribute to talent management and professional development of QA personnel.
- Develop, review, and approve QA documentation as related to general QA activities.
- Provide oversight of batch record review, deviation investigations, change controls, and product release decisions.
- Support quality meetings and key quality metrics and trends.
- Communicate effectively with internal and external stakeholders, including the AbbVie Quality and Compliance Group and regulatory bodies.
- Serve as a designee for the Biologics Quality Director as required.
