Vice President, Quality Assurance
The Vice President of Quality Assurance (QA) will lead Corcept’s QA group and the continued development of its Quality Management System. The QA VP will be accountable for all aspects of product quality at all stages, from clinical development to commercial availability and will be a critical member of cross-functional teams supporting regulatory filings. The QA VP will do this while fostering a collaborative, customer-focused approach that is focused on helping Corcept achieve its clinical and commercial goals while remaining fully-compliant with applicable QA requirements and Corcept’s patient-first ethos.Essential Duties/Tasks
- Help Corcept achieve its goals while ensuring compliance with applicable domestic and international current good practice quality guidelines and regulations including Good Manufacturing, Clinical, Laboratory, Distribution and Pharmacovigilance Practices (collectively, “GxPs”) and with Corcept’s specifications, procedures, and clinical requirements.
- Develop and manage a team of QA personnel whose attitude and capabilities align with Corcept’s focus of putting patients first, complying with policies and procedures and with all applicable rules and regulations, including GxP.
- Build collaborative working relationships with Quality teams at outsourced vendors
- Oversee and cultivate the QA team’s many internal cross-functional working groups to foster a collaborative, solutions-oriented approach.
- Provide regular reports to Senior Management regarding the performance, effectiveness and strategies for continuous improvement of quality metrics. Help distill complex issues into actionable solutions/options for Senior Management.
- Prepare for and manage regulatory agency inspections.
- Identify improvements to GxP Standard Operation Procedures (SOPs)
- Oversee cross-functional teams working on FDA and other regulatory inspections, including inspection preparation, hosting, and responding to observations
- Travel required
- 20+ years of experience in the biopharma industry, with 15+ years of experience in pharmaceutical QA, including 5+ years as the Head of Quality. At least 8+ years of experience in positions of substantial management responsibility within QA.
- At least 5 years experience working with outsourced development & manufacturing vendors.
- In depth knowledge of GxP and other applicable regulatory requirements; experience working with EU “Qualified Persons”
- Experience with small molecule manufacturing and oral dosage forms
- Demonstrated success building a successful quality organization
- Expert knowledge of relevant scientific principles and concepts
- Experience with regulatory agency inspection; recent PADER, PAI and/or BIMO inspection is highly desirable
- Excellent communication, leadership and collaboration skills.
Position Location – Must be located in the North California/Bay Area. Out of state applications will only be considered if you have indicated that you are willing to relocate to the Northern California/Bay Area.