Director, Clinical Quality Assurance
Corcept Therapeutics
June 26, 2026
Remote friendly (Redwood City, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead Clinical Quality Assurance activities as line manager to assigned CQA Leads and work with therapeutic area teams to support Corcept-sponsored clinical studies.
- Lead, manage, and train others on GCP audits (e.g., investigative site, vendor, internal, TMF, and study document audits incl. CSRs).
- Serve as QA representative to provide compliance advice and strategy for clinical study teams, therapeutic areas, and clinical product/study development.
- Drive review/approval of clinical study documents and clinical SOPs/guidance as required.
- Manage CSAP compliance using a risk-based approach.
- Lead continuous improvement of the CQMS, including SOP/training creation and revision for GCP compliance.
- Set and manage inspection readiness strategy; support GCP inspection preparation.
- Support/manage regulatory agency clinical inspections (sponsor, site, CRO); support GMP/GLP/PV inspections as needed.
- Conduct/manage qualification audits; review TMFs and CSRs.
- Lead/support clinical non-compliance investigations and CAPA implementation.
- Conduct CQA quality metric analyses (process deviations/CAPAs incl. protocol deviations, safety, and clinical data review).
- Lead GCP regulatory surveillance program; maintain agency/industry GCP trends knowledge.
- Provide cross-training, mentoring, and coaching; travel required.
Preferred Skills, Qualifications & Technical Proficiencies:
- Ability to prepare for and defend regulatory agency inspections.
- GCP audits experience (required).
- Experience developing GCP SOPs and training personnel.
- Understanding of quality systems supporting internal GCP and clinical documentation.
- Advanced Microsoft Office skills (Word, Excel, PowerPoint).
- Experience developing GCP processes and training.
Preferred Education & Experience:
- BA/BS in biological sciences, pharmacy, or related field (or equivalent experience) (required).
- 12+ years in clinical quality systems development/maintenance and performing GCP audits (preferred).
- Lead Clinical Quality Assurance activities as line manager to assigned CQA Leads and work with therapeutic area teams to support Corcept-sponsored clinical studies.
- Lead, manage, and train others on GCP audits (e.g., investigative site, vendor, internal, TMF, and study document audits incl. CSRs).
- Serve as QA representative to provide compliance advice and strategy for clinical study teams, therapeutic areas, and clinical product/study development.
- Drive review/approval of clinical study documents and clinical SOPs/guidance as required.
- Manage CSAP compliance using a risk-based approach.
- Lead continuous improvement of the CQMS, including SOP/training creation and revision for GCP compliance.
- Set and manage inspection readiness strategy; support GCP inspection preparation.
- Support/manage regulatory agency clinical inspections (sponsor, site, CRO); support GMP/GLP/PV inspections as needed.
- Conduct/manage qualification audits; review TMFs and CSRs.
- Lead/support clinical non-compliance investigations and CAPA implementation.
- Conduct CQA quality metric analyses (process deviations/CAPAs incl. protocol deviations, safety, and clinical data review).
- Lead GCP regulatory surveillance program; maintain agency/industry GCP trends knowledge.
- Provide cross-training, mentoring, and coaching; travel required.
Preferred Skills, Qualifications & Technical Proficiencies:
- Ability to prepare for and defend regulatory agency inspections.
- GCP audits experience (required).
- Experience developing GCP SOPs and training personnel.
- Understanding of quality systems supporting internal GCP and clinical documentation.
- Advanced Microsoft Office skills (Word, Excel, PowerPoint).
- Experience developing GCP processes and training.
Preferred Education & Experience:
- BA/BS in biological sciences, pharmacy, or related field (or equivalent experience) (required).
- 12+ years in clinical quality systems development/maintenance and performing GCP audits (preferred).