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.