Associate Director Quality Compliance / QA Client
Core
Strategic and operational leadership of the Quality Compliance and QA Client team to ensure regulatory compliance and continuous improvement of the quality management system.
Role type
Senior leadership IC quality compliance director
Builds
Sterile injectable pharmaceuticals (oncology therapeutics) and related services
Domain
Pharmaceutical manufacturing (CDMO) / Oncology
Required skills
GMP compliance, FDA/EMA regulations, Data Integrity, Audit/Inspection management, Team leadership, Regulatory Intelligence, Release Management, CAPA management
Preferred skills
Sterile manufacturing experience, CDMO background, Inspection readiness programs
Technologies
GMP systems, Quality Management Systems
Responsibilities
Lead and develop teams in Client Communication, Auditing, Data Integrity, Regulatory Intelligence, and Release Management; Ensure audit and inspection readiness including planning and follow-up of CAPAs; Represent the quality department in regulatory and customer audits; Monitor Data Integrity compliance within GMP processes; Lead internal compliance assessments and self-inspection programs; Build and maintain a global network for quality system development; Foster a sustainable quality and speak-up culture; Support continuous improvement and operational excellence projects.
