Corcept Therapeutics · 2 weeks ago
Senior Director, Quality Compliance
Redwood City, CA
Full-time
Onsite
Director/Executive
$262K/yr - $308K/yr
15+ years expCorcept Therapeutics is leading the way in the research and development of cortisol modulators. The Senior Director, Quality Compliance will lead the Quality Compliance team, ensuring adherence to the Corcept Quality Management System and overseeing various quality programs to drive compliance and continuous improvement.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
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
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
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)
Company
Corcept Therapeutics
Corcept Therapeutics discovers and develops drugs that regulate the effects of cortisol.
501-1000 employees
H1B Sponsorship
Corcept Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (4)
2023 (4)
2022 (3)
Funding
Current Stage
Public CompanyTotal Funding
$119.09MKey Investors
Paperboy Ventures
2012-07-02IPO
2012-04-10Post Ipo Equity· $0.53M
2011-01-21Post Ipo Equity· $39M
Leadership Team
Roberto Vieira
President, Oncology
Yuan Xu
Associate Director, Statistical Programming
Recent News
2026-01-24
2026-01-24
legacy.thefly.com
2026-01-23
Company data provided by crunchbase