Batch Release Lead
Core
Providing Quality Assurance oversight for final drug substance disposition, batch release, deviation management, change control, and Product Quality Review activities to ensure compliance with GMP and regulatory standards.
Role type
Senior Quality Assurance Lead (Pharmaceutical Manufacturing)
Builds
Drug substance batches for release to secondary customers
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Deviation management, batch release/disposition, root cause analysis, change control, Product Quality Reviews (PQR), GMP compliance, quality investigations, audit support, continuous improvement, stakeholder management, project management
Preferred skills
Analytical skills, problem-solving, performance metrics analysis, cross-functional communication
Technologies
GMP, Quality Assurance systems
Responsibilities
Perform final drug substance disposition and review batch-related quality information; investigate and resolve deviations impacting batch release; act as QA reviewer for site deviations and lead root cause analysis; review and approve change controls; perform Product Quality Reviews (PQR); participate in internal/external audits and regulatory inspections; identify and implement continuous improvement initiatives.
Seniority
Senior, hands-on IC
