Senior Product QA Manager
Location: Sligo
My client is seeking a Senior Product QA Manager to lead quality operations and ensure all manufactured products exceed regulatory (FDA, HPRA) and company standards. This pivotal role oversees compliance for commercial products and New Product Introductions (NPI), managing a high-performing team of QP, Regulatory, and Change Management professionals.
Key Responsibilities
- Leadership: Manage and develop the QP, Regulatory, and NPI teams, overseeing performance, talent management, and goal setting.
- Quality Governance: Lead batch review and release processes; oversee manufacturing/testing validation and record-keeping.
- Compliance & Regulatory: Act as the primary point of contact for FDA/HPRA inspections; manage regulatory submissions and execute requests.
- Change Management: Chair Change Review Boards and provide quality oversight on deviations, exceptions, and planned changes.
- Operational Excellence: Oversee complaint investigations, product recalls, and internal/external audits.
- NPI Support: Drive quality strategy for New Product Introductions, including CTS batch release and validation approval.
- Strategic Oversight: Manage site quality metrics, review PQRs, and act as the Designee for the Quality Director.
Key Qualifications & Experience
- Education: MSc in Industrial Pharmaceutical Science (or equivalent meeting QP status per Directive 2001/83/EC).
- Experience: 10+ years in the pharmaceutical/healthcare sector within FDA/EMA-regulated environments.
- Leadership: 7+ years in a management role with a proven track record of developing technical teams.
- Technical Knowledge: Deep expertise in FDA CFR Parts 210/211 and EU GMP (ICH Q7).
- Soft Skills: High integrity, innovative problem-solving abilities, and excellent communication skills for presenting technical data to stakeholders.
Why Join My Client?
This is a high-impact leadership opportunity to shape the quality culture of a major manufacturing site while driving the successful launch of new pharmaceutical innovations.
