Senior Product Quality Assurance Manager.

Senior Product QA Manager / Qualified Person (QP) Essential Requirements Qualified Person (QP) status under Article 49 of Directive 2001/83/EC. MSc in Industrial Pharmaceutical Science or equivalent qualification recognised for QP eligibility. 10+ years' experience within regulated pharmaceutical or healthcare manufacturing environments. Strong experience operating within FDA, EMA, HPRA and EU GMP regulated facilities. 7+ years' experience leading Quality Assurance, Regulatory Affairs, Change Management, or Compliance teams. Proven batch certification and release experience as a QP. Key Experience Areas Product Quality Assurance leadership. Regulatory submissions and direct interaction with regulatory agencies. New Product Introduction (NPI) and Tech Transfer projects. Change Control and Quality Risk Management. Deviations, CAPAs, investigations and product complaints. Validation oversight (process, cleaning, analytical methods). Internal, external and regulatory inspections. Product Quality Reviews (PQR/APR). SAP and LIMS quality systems. Product recall management. Quality metrics reporting and governance. Marketing Authorisation compliance. Cross-functional leadership across QA, Regulatory, Manufacturing and Technical Operations. Ideal Candidate Profile Existing Qualified Person (QP) or Senior QA Leader with QP eligibility. Extensive pharmaceutical manufacturing experience within highly regulated GMP environments. Demonstrated success leading multiple quality functions and developing high-performing teams. Strong understanding of FDA CFR Parts 210/211, EU GMPs, ICH guidelines and regulatory expectations. Experience supporting product launches, commercial manufacturing and lifecycle management. Comfortable leading regulatory inspections and presenting to senior leadership. Leadership & Personal Attributes Strong people leadership and talent development skills. Excellent communication and stakeholder management abilities. Highly organised with exceptional attention to detail. Strong problem-solving and decision-making capability. Results-driven with the ability to prioritise effectively in a fast-paced environment. High integrity and commitment to quality and compliance. Able to influence and collaborate across all levels of an organisation. Bonus, pension, healthcare and additional benefits typically available depending on the organisation and scope of responsibility. Candidate Search Keywords Qualified Person (QP) | Senior QA Manager | Product Quality Assurance | Batch Release | GMP | FDA | EMA | HPRA | Regulatory Affairs | Change Control | NPI | Tech Transfer | Pharmaceutical Manufacturing | Compliance | Validation | Quality Systems | Product Quality Review | CAPA | Deviations | Inspection Readiness | QMS | SAP | LIMS.