Senior Director, Quality Compliance

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.