For more than 25 years, Corcept has been singularly focused on the science of cortisol, a powerful hormone that when unregulated, can play a role in a broad range of diseases.
Our commercial portfolio includes treatments for hypercortisolism and oncology, and the company has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. With advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease, Corcept is unlocking the power of cortisol modulation to help address some of the most devastating diseases patients face today. Corcept is headquartered in Redwood City, California. To learn more, visit www.corcept.com.
Lead the Quality Compliance team responsible for monitoring and supporting adherence to and compliance with the Corcept Quality Management System (QMS). Oversee QMS compliance-related cross-functional quality programs (e.g., Inspection Readiness, audits, Quality Management Review, regulatory intelligence, and quality event oversight) to drive compliance and continuous improvement.
Responsibilities:
- Establish, develop, and lead the Quality Compliance team, including through mentorship and development of team members
- Partner with other Quality Assurance (QA) team and departments responsible for manufacturing, clinical, pharmacovigilance, and other development operations to ensure compliance with the Corcept Quality Management System (QMS)
- Support changes to the QMS made by other departments and QA teams to assure compliance with Corcept’s Quality Policy and GxP regulations
- Lead Quality Management Review (QMR)
- Oversee supplier management program, internal audit program, and quality event management, including investigations, corrective and preventative actions, and other needed follow up
- Implement and manage regulatory intelligence program, ensuring timely updates to the QMS required by changing regulations
Preferred Skills, Qualifications and Technical Proficiencies:
- Deep knowledge of global GxP regulations, trends, and quality systems
- Strong skills in audit planning, root cause analysis, and quality event management
- Familiarity with quality systems software (e.g., Veeva, ComplianceWire)
- Exceptional communication, leadership, and stakeholder management skills
- Ability to drive process improvements and foster a culture of compliance
Preferred Education and Experience:
- 15+ years of Quality Assurance experience in the biopharma industry, including experience leading compliance teams
- Global inspection experience strongly preferred
- Demonstrated experience in QMS leadership and building, including core responsibilities like QMR, internal audits, and quality events management, and regulatory inspections (e.g., FDA, EMA, PMDA)
The pay range that the Company reasonably expects to pay for this headquarters-based position is $261,500 – $307,600; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.
Applicants must be currently authorized to work in the United States on a full-time basis.
For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link.
Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs.
Please visit our website at: https://www.corcept.com/
Corcept is an Equal Opportunity Employer
Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.
Top Skills
What We Do
Leading the field in the discovery of drugs that modulate the effects of cortisol. The adverse effects of excess cortisol have been Corcept’s focus since the company’s inception. Abnormal levels and release of cortisol play a role in a variety of metabolic, oncological, and psychiatric diseases, and we are currently studying a new generation of compounds that may mitigate the effects of excess cortisol.
