Senior Director Quality Assurance & QP (m/w/d)
Core
Lead Quality Assurance and Qualified Person (QP) for a CDMO manufacturing biopharmaceuticals, ensuring GMP compliance, regulatory approvals, and supplier quality for drug substance production.
Role type
Senior Director, Quality Assurance & Qualified Person (QP)
Builds
Biopharmaceutical drug substances for global customers
Domain
Biopharmaceutical manufacturing / CDMO
Required skills
GMP compliance, Qualified Person (QP) regulatory authority, supplier quality management, team leadership (10+ people), risk management, project management, SAP material management, regulatory affairs interface
Preferred skills
CDMO environment experience, international customer management, strategic planning, innovation driving
Technologies
SAP
Responsibilities
Lead self-inspections, customer audits, and regulatory inspections; Manage supplier qualification and audits; Approve drug substance batches; Lead a 10-person QA team; Coordinate regulatory submissions and Q-questions; Manage complaint handling (SCAR)
Seniority
Senior Director, strategic leadership & hands-on regulatory authority