Senior Quality Manager – Drug Products
Core
Lead plant-wide Quality programs and compliance activities for drug products, overseeing CAPAs, non-conformances, and internal audit readiness.
Role type
Senior Quality Manager (Drug Products)
Builds
Drug product manufacturing operations compliant with regulatory standards
Domain
Pharmaceutical manufacturing / Medical Technology
Required skills
GMP experience, Root cause analysis, Change management, Validation and qualification, Risk management, Audit leadership, Team leadership, Continuous improvement methodologies, Regulatory compliance knowledge, Data analysis
Preferred skills
Engineering or Life Sciences degree, Six Sigma Certification
Technologies
Minitab, SAP, TrackWise
Responsibilities
Lead plant-wide Quality programs and compliance activities, Drive Quality oversight for change control and engineering initiatives, Champion continuous improvement initiatives, Own Annual Product Reviews (APRs), Analyze quality data and trends to identify risks, Empower and coach Quality teams, Partner cross-functionally to implement corrective actions, Lead and develop Quality team members, Act as SME on QMS and drug product regulations, Support external audit readiness and execution
Seniority
Senior, hands-on IC with management responsibilities