Associate Director, Quality Assurance
Core
Provide quality oversight, disposition support, and strategic leadership for clinical supply chain activities to ensure supplies are available, fit for use, and compliant with regulatory requirements.
Role type
Senior IC Associate Director, Clinical Supplies Quality
Builds
Clinical development programs and clinical supply chain operations
Domain
Pharmaceutical industry + Clinical Supply Chain Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical supply operations expertise, cGMP compliance, deviation management, quality risk management, stakeholder engagement, continuous improvement methodologies, strategic leadership
Preferred skills
Medical Device/Combination Products experience, emerging technologies experience
Technologies
None explicitly listed
Responsibilities
Lead and execute quality strategies and continuous improvement initiatives; Evaluate and disposition Medical Device/Combination Product materials; Coordinate investigations related to deviations and significant quality events; Identify quality trends and compliance gaps; Provide technical expertise in clinical supply operations and integration activities
Seniority
Senior, hands-on IC with strategic leadership
