Associate Director External Quality
Core
Manage external supplier quality systems, ensure GMP compliance, and drive continuous improvement across the pharmaceutical supply chain.
Role type
Senior IC Associate Director, External Quality
Builds
Pharmaceutical supply chain quality assurance and regulatory compliance
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
cGMP knowledge, supplier quality management, quality system auditing, data analysis, regulatory compliance, project management, cross-functional collaboration, problem solving, negotiation, stakeholder influence
Preferred skills
Lean/Six Sigma, multi-site experience, Quality Assurance background, advanced scientific degree
Technologies
Veeva Vault
Responsibilities
Conduct annual supplier assessments and quality reviews; approve cGMP documentation (change requests, validation plans, product quality reviews); manage quality investigations and deviations; support regulatory agency inspections; lead quality audits; drive cost-saving and continuous improvement initiatives; mentor supplier management teams; liaise with suppliers on project delivery.
Seniority
Senior, hands-on IC
