Associate Director External Quality
Core
Provide end-to-end quality oversight and expert QA leadership for supplier-related projects, ensuring GMP and regulatory compliance from planning through commercial supply.
Role type
Associate Director, External Quality Assurance
Builds
Robust quality systems for biologic and synthetic drug substance/product supply chains
Domain
Pharmaceutical manufacturing / Biologics / Contract Manufacturing Organizations (CMOs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, supplier quality oversight, technology transfer validation, deviation management, risk assessment, change control, cross-functional leadership, problem-solving in regulated environments, negotiation, influencing
Preferred skills
Sterile drug product manufacture experience, Lean Six Sigma certification, multi-site/multi-functional experience, post-approval change management
Technologies
None stated
Responsibilities
Provide end-to-end quality oversight for supplier-related projects; Act as project quality lead for new supplier selection and NPI; Support QA activities for technology transfer and validation at external sites; Ensure quality oversight of CMOs and contractors; Lead change controls, deviation investigations, and CAPA; Represent Global Quality in the ESM organization; Drive continuous improvement initiatives; Support audit and inspection readiness; Contribute to post-validation and post-launch activities.
Seniority
Senior, hands-on IC with strategic oversight
