Associate Director, QMS & Compliance
Core
Lead the Quality Management System (QMS) and ensure regulatory compliance for a pharmaceutical manufacturing and analytical lab facility.
Role type
Associate Director, QMS & Compliance
Builds
Pharmaceutical manufacturing operations and CMC analytical lab services
Domain
Pharmaceutical manufacturing / Regulatory Affairs
Deliverable
client delivery
Required skills
QMS management, regulatory affairs, team leadership, budget management, continuous improvement, stakeholder management, technical writing, risk management
Preferred skills
commercial acumen, change management, strategic alignment, influencing capabilities
Technologies
GMP, FDA, MHRA, DMF
Responsibilities
Lead and maintain the Quality Management System (QMS) ensuring compliance with GMP, FDA, MHRA, and other regulatory requirements; Oversee regulatory affairs activities including filings, DMF maintenance, and authority enquiries; Drive operational excellence through QMS budget management and continuous improvement programs; Develop, coach, and lead a high-performing team with succession planning; Partner with customers, suppliers, and internal stakeholders to support business objectives.
Seniority
Senior, hands-on IC with leadership mandate
