Head of QA (w/m/d) GMP Compliance
Core
Ensuring GMP compliance and data integrity, leading the QA team, and managing quality processes in a pharmaceutical environment.
Role type
Senior leadership quality assurance manager (pharmaceuticals)
Builds
Quality management systems, regulatory compliance, and audit readiness for pharmaceutical clients
Domain
Pharmaceuticals / Regulatory Quality Assurance
Required skills
GMP compliance, CAPA management, audit management, quality documentation, complaint management, quality reporting, SOP development, risk analysis, team leadership, resource planning
Preferred skills
Technical understanding, strategic optimization, cross-functional collaboration, regulatory knowledge
Technologies
GMP systems, validation tools, quality management software
Responsibilities
Ensure GMP compliance and data integrity; Approve and monitor CAPA, change control, and deviation processes; Plan and follow up on regulatory inspections and customer audits; Maintain and update quality documents (e.g., Site Master File, Validation Master Plan); Manage complaints; Conduct self-inspections; Ensure timely creation of Product Quality Reviews; Create, analyze, and evaluate quality reports; Develop site-specific QM systems; Escalate quality-critical issues; Lead and develop the QA team; Coordinate with Production, QC, Engineering, Logistics, and Supply Chain; Communicate with authorities, customers, and suppliers; Travel readiness
Seniority
Senior, hands-on IC with leadership responsibilities
