Director, QA GMP Operations
Core
Managing GMP quality for external manufacturing operations and internal GMP operations for development and commercial programs in a biopharma setting.
Role type
Director, QA GMP Operations
Builds
Clinical and commercial biologic therapeutics for neuromuscular diseases
Domain
Biopharmaceuticals / Gene Therapy / Neuromuscular Diseases
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, deviation/OOS/OOT investigation, regulatory document review (IND/IMPD/BLA/MAA), batch record review, tech transfer oversight, process validation oversight, stakeholder management
Responsibilities
Manage external quality operations in support of GMP manufacturing (clinical and commercial) activities; Manage deviations, OOS and OOTs investigations while adhering to cGMP principles and ICH guidelines; Review batch records, analytical method reports and technical reports including regulatory sections of IND/IMPD and BLA/MAAs; QA support of Tech Transfer and Process Validation activities
Seniority
Director, management level