Associate Director – Quality, Compendial Compliance & Analytical Changes
Core
Manages organizational support for analytical standards, change control, and compendial compliance across a global manufacturing network to ensure regulatory alignment and supply continuity.
Role type
Senior leadership quality assurance manager (pharmaceutical manufacturing)
Builds
Compliant global supply of bio-pharmaceuticals
Domain
Pharmaceutical manufacturing and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, analytical change control, compendial surveillance, laboratory operations oversight, strategic project leadership, cross-functional stakeholder alignment, performance management, risk management, technical problem-solving in regulated environments
Preferred skills
Experience with USP/Ph. Eur./JP interpretation, succession planning, continuous improvement initiatives
Technologies
GMP systems, change control systems, performance management systems
Responsibilities
Supervise analytical standards maintenance and change control processes; provide quality oversight for manufacturing sites and R&D; recruit and mentor scientific personnel; lead inter-departmental projects; ensure compliance with regulatory expectations and pharmacopeial requirements
Seniority
Director, strategic oversight and team leadership