Associate Director, Quality Compliance

Corcept is committed to improving patient lives through the discovery and development of drugs that address serious unmet medical needs related to excess cortisol activity.  

Cortisol dysregulation plays an important role in a variety of endocrine, metabolic, oncologic, psychiatric, and ophthalmologic diseases. Corcept leads the field in the research and development of selective glucocorticoid receptor (GR) antagonists, having discovered more than 500 proprietary molecules since its founding in 1998.

The Associate Director, Quality Compliance will lead Corcept’s Quality Compliance function and have primary responsibility for overseeing internal audits, vendor qualification, and inspection readiness. This role reports to the Quality Systems Director and will be accountable for all aspects of GxP compliance with the FDA and standards and guidelines applicable to the business. The position will also include working with cross-functional teams to track and report revisions to regulations and determine impact to quality systems.

Responsibilities

Develop Corcept’s Quality Compliance function, establishing processes and infrastructure Attract and develop talent, creating a rewarding professional environment, and ensure that the team’s capabilities meet Corcept’s future needs Manage the Quality Compliance function, which is responsible for Inspection Readiness efforts, the Contract Service Provider (CSP) qualification program, and the audit program Manage and maintain the CSP qualification program and GxP CSP audits (follow up on open observations and ensure timely closure) Lead inspection readiness and collaborate with cross functional teams on FDA and other regulatory authority inspections, including inspection preparation, hosting, and respond to observations Coordinate and manage internal audits Manage responses to identified potential non-conformances by investigating and implementing preventative actions to ensure compliance with internal Standard Operating Procedures (SOPs) and regulatory authority requirements. As part of the greater Quality Systems team, support other projects and responsibilities as needed, including without limitation as related to the Document Control System, Document Management System, Quality Management System, and quality agreements Provide cross training development opportunities Mentor and coach junior QA team members

Preferred Education and Experience

BA/BS in a scientific discipline Strong knowledge of cGMP requirements including 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, PMDA, etc.) 15+ years’ experience in pharmaceutical QA including 5+ supporting Quality Systems Excellent written and oral communication skills. Knowledge of principles of validation of electronic Data Management System and Quality Management System Experience with Inspection Management and Hosting

Corcept has a dynamic and authentic culture where we remain true to our principles while embracing continued growth. Our work is marked by innovation, integrity, collaboration, and honest communication. We all have unique contributions to make, and our success is the sum of those contributions.

Our work is anchored in leading the discovery and development of drugs that modulate the effects of cortisol. Through our collaborations with researchers around the world, more than 30 studies are underway to investigate the potential benefits GR antagonists may have in the treatment of serious and life-threatening diseases.