Manager, Quality Operations
Corcept Therapeutics
August 11, 2026
Remote friendly (Redwood City, CA)
United States
Operations
Senior Manager/Associate Director, Quality Operations
Responsibilities:
- Lead Quality Operations for complex CMC, commercial, and clinical supply programs using strategic quality direction, risk-based decisions, and timely issue escalation.
- Provide quality oversight of contract manufacturing organizations (CMOs), contract testing labs (CLOs), suppliers, and external partners to ensure compliance with approved procedures, regulatory expectations, and quality agreements.
- Review and approve GMP documentation (batch records, analytical data, investigations, deviations, CAPAs, change controls, validation documentation, and product disposition records).
- Lead/oversee quality investigations for manufacturing, testing, packaging, labeling, storage, distribution, and product release; ensure timely RCA and effective CAPAs.
- Review/approve validation protocols and reports (process validation, analytical method validation, cleaning validation, packaging validation, shipping lane qualification as applicable).
- Lead/support audits of suppliers/CLOs/CMOs/service providers (planning, execution, reporting, corrective action follow-up).
- Develop, monitor, and communicate Quality metrics and trend reports for continuous improvement.
- Partner cross-functionally (CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, Commercial).
- Mentor Quality Operations and cross-functional teams to strengthen technical capability and inspection readiness.
Qualifications/Preferred Skills:
- Understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP.
- Quality judgment and risk assessment to support compliance, patient safety, and product quality.
- Experience with batch record review, deviations, CAPA, change control, validation, supplier quality, and quality agreements.
- Experience with inspections/audits and remediation.
- Ability to author/review/approve controlled documents (SOPs, quality agreements, risk assessments, technical reports).
- Strong analytical/problem-solving/communication skills; presents risks/metrics to senior management.
- Manages multiple priorities in a fast-paced matrix environment.
- Experience developing/presenting quality metrics/trends.
- Proficient with Microsoft Word/Excel/PowerPoint/Visio/Smartsheet and electronic QMS.
- Travel up to 20%.
Preferred Education/Experience:
- BS/MS in science/engineering/pharmacy or related (advanced degree preferred).
- 6+ years progressive Quality Assurance experience in regulated life sciences.
- Working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, and ICH guidelines.
Application instructions:
- Applicants must be authorized to work in the United States full-time.
Responsibilities:
- Lead Quality Operations for complex CMC, commercial, and clinical supply programs using strategic quality direction, risk-based decisions, and timely issue escalation.
- Provide quality oversight of contract manufacturing organizations (CMOs), contract testing labs (CLOs), suppliers, and external partners to ensure compliance with approved procedures, regulatory expectations, and quality agreements.
- Review and approve GMP documentation (batch records, analytical data, investigations, deviations, CAPAs, change controls, validation documentation, and product disposition records).
- Lead/oversee quality investigations for manufacturing, testing, packaging, labeling, storage, distribution, and product release; ensure timely RCA and effective CAPAs.
- Review/approve validation protocols and reports (process validation, analytical method validation, cleaning validation, packaging validation, shipping lane qualification as applicable).
- Lead/support audits of suppliers/CLOs/CMOs/service providers (planning, execution, reporting, corrective action follow-up).
- Develop, monitor, and communicate Quality metrics and trend reports for continuous improvement.
- Partner cross-functionally (CMC, Regulatory Affairs, Technical Operations, Supply Chain, Clinical Operations, Commercial).
- Mentor Quality Operations and cross-functional teams to strengthen technical capability and inspection readiness.
Qualifications/Preferred Skills:
- Understanding of pharmaceutical manufacturing, analytical testing, validation, quality systems, and global cGMP.
- Quality judgment and risk assessment to support compliance, patient safety, and product quality.
- Experience with batch record review, deviations, CAPA, change control, validation, supplier quality, and quality agreements.
- Experience with inspections/audits and remediation.
- Ability to author/review/approve controlled documents (SOPs, quality agreements, risk assessments, technical reports).
- Strong analytical/problem-solving/communication skills; presents risks/metrics to senior management.
- Manages multiple priorities in a fast-paced matrix environment.
- Experience developing/presenting quality metrics/trends.
- Proficient with Microsoft Word/Excel/PowerPoint/Visio/Smartsheet and electronic QMS.
- Travel up to 20%.
Preferred Education/Experience:
- BS/MS in science/engineering/pharmacy or related (advanced degree preferred).
- 6+ years progressive Quality Assurance experience in regulated life sciences.
- Working knowledge of 21 CFR Parts 210/211, 21 CFR Part 11, EU GMP, and ICH guidelines.
Application instructions:
- Applicants must be authorized to work in the United States full-time.