Associate Director, GMP Quality
Core
Ensuring GMP compliance for biologics manufacturing, testing, packaging, and distribution while integrating AI for quality efficiency.
Role type
Associate Director, GMP Quality Assurance (Biologics)
Builds
GMP-compliant biologics drug candidates for clinical trials and commercialization
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance (FDA/EMA/ICH), biologics/large-molecule manufacturing, batch release, deviation investigations, supplier/CDMO qualification, risk management (FMEA), regulatory inspection preparation
Preferred skills
AI integration in QA, virtual manufacturing oversight, CMO management
Technologies
AI tools for quality assurance
Responsibilities
Ensure compliance with global regulations and internal SOPs; Review and approve GMP documents; Perform QA review of batch records; Support investigations into deviations and quality events; Conduct internal audits; Qualify and assess suppliers and CDMOs; Review Quality Agreements; Support regulatory inspections; Apply risk management principles
Seniority
Senior, hands-on IC with leadership scope
