Associate Director, Quality
Core
Overseeing quality management for external suppliers across formulation, fill, finish, and packing categories to ensure GMP and regulatory compliance.
Role type
Senior IC quality director (supplier management)
Builds
Pharmaceutical supply chain quality systems and supplier compliance
Domain
Pharmaceutical industry + Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
cGMP knowledge, supplier assessment, regulatory compliance, data analysis, project management, cross-functional collaboration, problem-solving, negotiation
Preferred skills
Lean/Six Sigma, multi-site experience, Quality Assurance/Technical combination, Master's in QA/Regulatory Affairs
Technologies
Veeva Vault
Responsibilities
Conduct supplier assessments and quality reviews, manage quality agreements and data trending, support regulatory agency inspections, lead quality issue resolution, facilitate process improvements, develop business relationships with suppliers, participate in audits and self-inspections
Seniority
Senior, hands-on IC with strategic oversight