Senior Manager, Operational Area Quality (Combination Products)
Core
Senior Manager leading quality oversight for assembly manufacturing of medical devices and drug-device combination products, ensuring GMP compliance and product release.
Role type
Senior Manager, Operational Area Quality (Combination Products)
Builds
Medical devices and combination products (e.g., autoinjectors, prefilled syringes) for clinical and commercial markets
Domain
Medical device manufacturing / Combination products / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, deviation management, root cause analysis, supplier quality management, regulatory inspection support, design control alignment, risk management (FMEA), process validation, cross-functional leadership
Preferred skills
Statistical analysis (Minitab), quality engineering methodologies, autoinjector assembly expertise, CMO partnership experience
Technologies
Minitab, Electronic Batch Records (EBRs), Device History Records (DHRs)
Responsibilities
Lead quality assurance for assembly manufacturing; review and approve batch records and product disposition; lead investigations and CAPAs; partner with CMOs on quality agreements; support process validation and technology transfers; lead supplier quality activities; support regulatory and customer audits; contribute to risk management files
Seniority
Senior Manager, hands-on technical leadership with people management
