Sr. Manager, Quality Assurance
Core
Provide strategic and operational leadership for batch disposition, compliance oversight, and quality systems supporting clinical and commercial manufacturing.
Role type
Senior Manager, Quality Assurance
Builds
Clinical and commercial manufacturing batches at RTP facility
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP expertise, batch disposition, investigations, CAPA, change control, document management, validation, regulatory compliance (FDA/EMA), team leadership
Preferred skills
Advanced degree (MS/MBA), clinical and commercial manufacturing experience, executive presentation, internal audit leadership
Technologies
None stated
Responsibilities
Lead quality oversight activities across multiple quality systems, Provide final batch disposition decisions, Partner with Manufacturing and Engineering leaders, Drive continuous improvement of quality systems, Analyze site quality metrics and implement solutions, Lead internal audits and support regulatory inspections, Hire and mentor a team of quality professionals
Seniority
Senior, Management
