Director, Compliance & Quality Systems
Core
Lead the design, implementation, and ongoing operation of a comprehensive Quality Management System (QMS) in a regulated laboratory environment, ensuring alignment with GMP requirements and client expectations.
Role type
Director, Quality & Compliance
Builds
A scalable QMS framework embedded within a connected technology platform for a regulated laboratory
Domain
Life Sciences / Biopharmaceuticals / Regulated Laboratory Operations
Required skills
GMP compliance, QMS design and implementation, regulatory inspection readiness, internal audit management, supplier quality management, data integrity (ALCOA+), team leadership, risk management, change control, CAPA, document control
Preferred skills
ISO 9001/17025 standards, Computerized System Validation (GAMP 5), software development lifecycle knowledge, quality certifications (CQA/CQE/CMQ/OE), CDMO experience
