Senior Manager, Quality Assurance GCP
Crinetics Pharmaceuticals
14 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Position: Senior Manager, Quality Assurance (GCP)
Responsibilities:
- Manage, oversee, conduct, and report on assigned GCP and GLP qualification/routine vendor audits (e.g., TMF, clinical site, data, clinical documents).
- Develop and maintain annual audit programs and schedules.
- Track and trend audit findings/CAPAs and drive preventive actions.
- Perform vendor risk assessments; maintain/archive QA electronic vendor files and audit documentation.
- Reconcile master vendor tracker and vendor records; manage GCP/GLP quality agreements.
- Attend vendor governance/oversight meetings.
- Provide GCP guidance for R&D; participate in clinical study team meetings.
- Identify/escalate significant compliance risks; support Trial Master File (TMF) activities.
- Review moderate-complexity clinical documents (protocols, ICFs, study plans, IB, CSR) and provide feedback.
- Review deviations/quality issues/CAPAs; conduct investigations and root-cause analysis.
- Interpret and apply global regulations of moderate complexity; identify compliance gaps and implement improvements.
- Support inspection-readiness and regulatory inspections.
- Develop/execute SOPs and training; administer GCP training.
Required:
- Bachelor’s degree + 12+ years in pharma/biotech QA.
- Ability to interpret FDA/EU/ICH and other global GCP regulations.
- Prior GCP QA audit experience (vendor, investigator site, internal); lead/supervise auditors.
- Knowledge of QMS for vendor management, SOPs, internal audits, deviations, and CAPAs.
- Strong analytical/problem-solving, collaboration, communication, organization, and risk-based approach.
Preferred:
- GLP/GVP experience.
- Regulatory inspection experience; auditor certification/RQAP-GCP (plus).
Travel: Up to 35%.
Comp/Benefits (as stated): $133,000–$166,000; discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.
Responsibilities:
- Manage, oversee, conduct, and report on assigned GCP and GLP qualification/routine vendor audits (e.g., TMF, clinical site, data, clinical documents).
- Develop and maintain annual audit programs and schedules.
- Track and trend audit findings/CAPAs and drive preventive actions.
- Perform vendor risk assessments; maintain/archive QA electronic vendor files and audit documentation.
- Reconcile master vendor tracker and vendor records; manage GCP/GLP quality agreements.
- Attend vendor governance/oversight meetings.
- Provide GCP guidance for R&D; participate in clinical study team meetings.
- Identify/escalate significant compliance risks; support Trial Master File (TMF) activities.
- Review moderate-complexity clinical documents (protocols, ICFs, study plans, IB, CSR) and provide feedback.
- Review deviations/quality issues/CAPAs; conduct investigations and root-cause analysis.
- Interpret and apply global regulations of moderate complexity; identify compliance gaps and implement improvements.
- Support inspection-readiness and regulatory inspections.
- Develop/execute SOPs and training; administer GCP training.
Required:
- Bachelor’s degree + 12+ years in pharma/biotech QA.
- Ability to interpret FDA/EU/ICH and other global GCP regulations.
- Prior GCP QA audit experience (vendor, investigator site, internal); lead/supervise auditors.
- Knowledge of QMS for vendor management, SOPs, internal audits, deviations, and CAPAs.
- Strong analytical/problem-solving, collaboration, communication, organization, and risk-based approach.
Preferred:
- GLP/GVP experience.
- Regulatory inspection experience; auditor certification/RQAP-GCP (plus).
Travel: Up to 35%.
Comp/Benefits (as stated): $133,000–$166,000; discretionary annual target bonus, stock options, ESPP, 401k match; medical/dental/vision/basic life; 20 days PTO, 10 paid holidays, winter company shutdown.