Manager, Quality Assurance Operations

Corcept is a leading company in the research and development of cortisol modulators, with a focus on unlocking the possibilities of cortisol modulation as a way to treat serious diseases. The Quality Assurance Operations Manager is responsible for various operational activities to assure product quality and compliance in the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product.

Requirements

• Act as Quality lead and support in various Chemistry, Manufacturing and Controls (CMC) projects
• Work cross-functionally with the CMC group to provide oversight and resolve quality investigations
• Perform review of executed batch records and test data
• Lead and support quality audit of contract service providers
• Develop, review, and revise Standard Operating Procedures (SOPs)
• Generate and review Quality and Technical Agreements with Contract Service Providers (CSP)
• Perform quality trends analysis and reports
• Support the management and growth of the Quality Assurance Operations team