Associate Director, Clinical Quality Assurance
Corcept Therapeutics
August 06, 2026
Remote friendly (Redwood City, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead Clinical Quality Assurance activities and oversee assigned CQA team members to ensure compliance oversight of clinical studies within a clinical development program.
- Support management and growth of the CQA team.
- Develop/manage study audit plans using a risk-based approach.
- Lead/manage Good Clinical Practice (GCP) audits (clinical investigator site, Trial Master File (TMF), and applicable study documents including CSRs).
- Support clinical service provider and internal process audits.
- Assess changes to qualified service provider services and impacts to ongoing studies.
- Serve as CQA Lead representative on assigned clinical studies throughout the study lifecycle.
- Evaluate new processes/initiatives impacting clinical programs/studies and support implementation.
- Support clinical teams with risk management (identify CtQ factors, implement risk-proportionate activities, monitor risks).
- Review clinical study documents/plans and provide CQA compliance review/approval of clinical development SOPs.
- Manage GCP inspection readiness and support regulatory inspections (sponsor, site, service provider).
- Lead critical investigations for regulatory reporting compliance.
- Support, review, and approve clinical non-compliance records (deviations and CAPA).
- Lead continuous improvement of the Clinical Quality Management System (CQMS), including SOPs and GCP training.
- Maintain knowledge of GCP trends/standards/methodologies.
- Cross-train, mentor, and coach junior QA team members.
- Travel required.
Qualifications/Skills:
- Ability to prepare for and defend regulatory agency inspections; perform GCP audits (required).
- Experience developing GCP SOPs and training personnel on SOPs and related regulations.
- Thorough understanding of quality systems supporting internal GCP activities.
- Proficient with Microsoft Office (Word, Excel, PowerPoint) (required).
Education/Experience:
- BA/BS in biological sciences, pharmacy, related field, or equivalent experience (required).
- 10+ years developing/maintaining clinical quality systems and performing GCP audits for clinical-stage pharmaceutical companies.
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.
- Lead Clinical Quality Assurance activities and oversee assigned CQA team members to ensure compliance oversight of clinical studies within a clinical development program.
- Support management and growth of the CQA team.
- Develop/manage study audit plans using a risk-based approach.
- Lead/manage Good Clinical Practice (GCP) audits (clinical investigator site, Trial Master File (TMF), and applicable study documents including CSRs).
- Support clinical service provider and internal process audits.
- Assess changes to qualified service provider services and impacts to ongoing studies.
- Serve as CQA Lead representative on assigned clinical studies throughout the study lifecycle.
- Evaluate new processes/initiatives impacting clinical programs/studies and support implementation.
- Support clinical teams with risk management (identify CtQ factors, implement risk-proportionate activities, monitor risks).
- Review clinical study documents/plans and provide CQA compliance review/approval of clinical development SOPs.
- Manage GCP inspection readiness and support regulatory inspections (sponsor, site, service provider).
- Lead critical investigations for regulatory reporting compliance.
- Support, review, and approve clinical non-compliance records (deviations and CAPA).
- Lead continuous improvement of the Clinical Quality Management System (CQMS), including SOPs and GCP training.
- Maintain knowledge of GCP trends/standards/methodologies.
- Cross-train, mentor, and coach junior QA team members.
- Travel required.
Qualifications/Skills:
- Ability to prepare for and defend regulatory agency inspections; perform GCP audits (required).
- Experience developing GCP SOPs and training personnel on SOPs and related regulations.
- Thorough understanding of quality systems supporting internal GCP activities.
- Proficient with Microsoft Office (Word, Excel, PowerPoint) (required).
Education/Experience:
- BA/BS in biological sciences, pharmacy, related field, or equivalent experience (required).
- 10+ years developing/maintaining clinical quality systems and performing GCP audits for clinical-stage pharmaceutical companies.
Application instructions:
- Applicants must be currently authorized to work in the United States on a full-time basis.