Manager, Quality Assurance Operations

About this role

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators.


In 2012, we received FDA approval of Korlym® (mifepristone), the first approved treatment for hypercortisolism (Cushing’s syndrome).


Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation.


What began as a ripple of scientific truth
is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease.


The Quality Assurance Operations Manager is responsible for a variety of operational activities pertaining to assuring product quality and compliance with the manufacture, testing, control, validation, and release of pharmaceutical drug substance and drug product for commercial and clinical distribution. This role will also be responsible for the oversight of 3PLs and work closely with the QPs to distribute products in EU. This is a remote role.


Responsibilities:

• 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 of issues that occur at contract manufacturing and testing organizations
• Perform review of executed batch records and test data and perform product disposition
• Review and approval of validation protocols and reports (e.g., process, method, etc.)
• Lead and support quality audit of contract service providers
• Develop, review, and revise Standard Operating Procedures (SOPs) to reflect current ind...