QA Lead - European Operations (Pharmaceuticals)
A global pharmaceutical organization is seeking a QA Lead to oversee European quality operations. This senior role is accountable for establishing and maintaining a compliant, inspection-ready Pharmaceutical Quality System (PQS) supporting Marketing Authorisation Holder (MAH) and Wholesale Distribution Authorisation (WDA) activities.
This is a hands-on, strategic leadership role, combining operational delivery with high-level regulatory engagement. The QA Lead will design and deploy a lean, scalable quality system, oversee external manufacturing and testing partners, and act as the primary quality interface with European regulators. The role also supports future Manufacturing/Import Authorisation (MIA) readiness within a growing global organisation.
Key Responsibilities
- Design, implement, and maintain a fit-for-purpose PQS aligned with EU GMP, GDP, and ICH Q10.
- Lead deployment and administration of a digital eQMS (document control, deviations, CAPA, change control).
- Author and govern quality manuals, SOPs, and policies.
- Establish training programs and drive continuous improvement and inspection readiness.
- Act as QA representative for MAH and WDA compliance under EU/UK legislation.
- Serve as primary QA contact during HPRA, MHRA, and other regulatory inspections.
- Ensure compliant product release, distribution, recalls, and rapid alerts.
- Partner closely with the Responsible Person (RP) on GDP compliance.
- Establish and manage supplier qualification and audit programs.
- Oversee CMOs, contract labs, and service providers.
- Develop and maintain Quality and Technical Agreements.
- Monitor supplier performance through metrics and escalation pathways.
- Oversee batch documentation review, complaints, PQRs, and quality trending.
- Lead investigations, risk assessments, and CAPA implementation.
- Collaborate cross-functionally on post-approval changes and lifecycle management.
- Lead Quality Risk Management activities.
- Contribute to quality governance, management review, and European quality strategy.
- Provide senior leadership with regulatory insight and quality risk assessments.
- Collaborate with international quality and technical teams.
- Partner with Regulatory, Supply Chain, and Commercial functions to embed quality by design.
Qualifications & Experience
- 12+ years' experience in pharmaceutical QA/compliance (MAH, CMO oversight, or distribution environments).
- Degree in a life science discipline; advanced degree desirable.
- Proven experience designing or modernising GMP/GDP-compliant QMS/PQS.
- Strong inspection experience with EU/UK regulators.
- Deep knowledge of EU/UK MAH obligations and GDP requirements.
- Experience with digital quality systems (e.g., Veeva, TrackWise, MasterControl).
- Excellent stakeholder engagement and leadership skills.
