Sr Manager, Quality Assurance
Core
Lead a team responsible for quality oversight of packaging operations, ensuring compliance with GMP requirements, regulatory expectations, and product labelling requirements.
Role type
Senior Manager, Quality Assurance Operations (Packaging)
Builds
Compliant packaging operations and uninterrupted product supply to patients
Domain
Pharmaceutical manufacturing (GMP)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP pharmaceutical industry experience, QA leadership, deviation management, CAPA management, risk-based quality culture, stakeholder management, regulatory inspection support, data integrity management
Preferred skills
Master's degree in Science/Engineering, cross-functional risk management, SAP/MES/EBR system expertise
Technologies
SAP, MES, Electronic Batch Records (EBR)
Responsibilities
Lead QA personnel for batch record and artwork review; drive identification and mitigation of quality/compliance risks; coach and develop high-performing QA team; oversee Functional Service Provider team; ensure alignment with global data standards for master data
Seniority
Senior, hands-on IC with leadership responsibilities