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 e QMS (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, Track Wise, Master Control).
Excellent stakeholder engagement and leadership skills.
Skills: QA GMP Quality Assurance