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Corcept Therapeutics · 7 hours ago

Senior Director, Quality Compliance

Redwood City, California, United States

Full-time

Onsite

Director/Executive

$262K/yr - $308K/yr

15+ years exp

Corcept Therapeutics is leading the way in the research and development of cortisol modulators, aiming to treat serious diseases. The Senior Director of Quality Compliance will lead the Quality Compliance team, ensuring adherence to the Quality Management System and overseeing compliance-related quality programs.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Global GxP regulationsAudit planningQuality event managementQuality systems softwareQMS leadershipStakeholder managementProcess improvementsExceptional communicationLeadership skills

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

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)