Lead QA oversight for RD, analytical process development, and tech transfer.Ensure compliance with GMP, GLP, ICH, and global regulatory standards.Review and approve development protocols, validation reports, and CMC docs.Handle deviations, CAPAs, change controls, and data integrity (ALCOA+).Support audits, inspections, and regulatory filings (IND, BLA, DMF).Mentor and manage QA team, and drive quality culture across development.Skills Required
Strategic Planning, Financial Analysis, Project Management, Regulatory Compliance, Operations Management, Risk Assessment