We are now hiring a Senior Product QA Manager to join our team in Manorhamilton Road, Sligo. This leadership role ensures that all products manufactured at Sligo Manorhamilton Road meet the requirements of end users, regulatory authorities (including FDA and HPRA), and company standards. The Senior Product QA Manager is responsible for compliance with marketing authorisations, current Good Manufacturing Practices (GMP), and supporting New Product Introductions (NPIs).
Responsibilities:
- Manage QP , Regulatory, Change Management and New Product Introduction teams, including annual goal setting, performance reviews, development, and talent management.
- Ensure products (commercial and NPI/CTS) are manufactured and released in line with marketing authorisation, GMP, and company quality systems.
- Lead batch review and release, documentation, checks, and test completion.
- Oversee validation of manufacturing and testing processes and accurate record keeping.
- Provide quality governance on deviations, planned changes, and exception reporting with proper authorisations and regulatory notifications.
- Support NPI activities: change plan review, validation, documentation approval, and release of CTS batches.
- Execute regulatory requests and submissions, engage directly with regulatory agencies (FDA, HPRA).
- Chair Change Review Boards, approve changes, oversee completion of QA tasks.
- Conduct internal/external audits and participate in regulatory/customer inspections.
- Manage complaint investigations, coordinate product recalls, and address quality defects.
- Ensure compliance with FDA CFR Parts 210/211/Q7, EU GMPs (ICH Q7, Volume 4), and AbbVie QA Policies.
- Review and approve Product Quality Reviews (PQRs) and track finished product data.
- Provide QP oversight for SAP, LIMS setup changes, and manage site quality metrics.
- Act as Designee for the Quality Director when required.
- Lead department/site goals, provide technical leadership/guidance on QP/regulatory matters, and present technical data for decision-making.