Director, GMP and Quality Systems Compliance

Director, GMP and Quality Systems Compliance, reporting to the Senior Director, Quality Assurance, responsible for leading and overseeing compliance across GMP and Quality Systems. Establish procedural and system requirements for Supplier and Contract Service Provider Quality Management, maintain inspection readiness across the clinical and future commercial network, develop Regulatory Intelligence, oversee internal audits and self-assessments, and coordinate annual Quality System reviews including QMR and Annual Product Reviews after commercial launch. Based in Cambridge, MA or San Francisco, CA with up to 25% travel.

• Supplier / Contract Service Provider Quality Management
  • Partner with regulated business functions to identify Suppliers and CSPs requiring quality and compliance oversight
  • Establish assessment mechanisms, risk-based controls, and monitoring and feedback loops for compliant oversight
  • Serve...