Senior Director, Quality Compliance
$262k - $308k USD
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.
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.
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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
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