Senior Director, Quality & Compliance

Lead Candidate are seeking a talented Quality and Compliance for a CDMO, to be based on site in California. The ideal candidate will have a can-do attitude, and a proven ability to lead projects and people.

Responsibilities

• Lead Quality & Compliance for all GMP operations, ensuring regulatory and client requirements are met
• Oversee QA team and approve batch records, validation, stability, and release documentation
• Manage core quality systems including CAPA, audits, training, document control, and stability programs
• Coordinate cross-functional activities to meet timelines and business goals
• Drive continuous improvement of quality systems, processes, and compliance maturity
• Manage QA operations: deviations, OOS investigations, vendor qualification, audits, and product release
• Lead regulatory inspections, client audits, and responses to observations and corrective actions
• Oversee validation lifecycle for facilities, utilities, equipment, and GMP systems
• Develop GMP metrics, training programs, and SOP improvements to strengthen compliance culture
• Act as primary liaison with regulatory agencies and maintain GMP licenses and approvals

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