Quality Compliance Lead
Core
Lead site Quality Compliance program and ensure effective operation of Quality Systems in accordance with GxP requirements and EU GMP Annex 1 for sterile manufacturing.
Role type
Senior IC Quality Compliance Lead (Sterile Manufacturing)
Builds
Robust and effective Quality Management System for sterile manufacturing operations
Domain
Pharmaceutical/Biotechnology manufacturing (Sterile)
Required skills
GxP compliance, EU GMP Annex 1, sterile manufacturing QA, Quality Systems governance, CAPA, change control, Quality Risk Management, Validation Program oversight, Annual Product Quality Reviews, team leadership
Preferred skills
Master's degree in relevant discipline, advanced analytical skills for quality metrics evaluation
Technologies
GxP systems, Quality Management Systems (QMS), Validation tools
Responsibilities
Lead site inspection readiness and coordinate regulatory inspections, host audits and manage observation responses, lead cross-functional Quality governance forums, monitor QMS effectiveness via metrics, provide oversight of Data Integrity and Data Governance programs, lead Validation Program governance, develop QA Compliance team, benchmark best practices across network
Seniority
Management level, hands-on IC with team leadership