Sr. Clinical QA Manager
Neurocrine Biosciences
July 01, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Responsible for driving and leading Clinical Quality Assurance (CQA) activities supporting research and development/commercial products across multiple therapeutic areas. Provides QA expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
Your Contributions
Good Clinical Practice (GCP) Audit Management:
- Lead, plan, conduct, and oversee GCP audits (vendor, investigator sites, internal)
- Develop and execute audit plans; oversee consultant auditors; manage stakeholder communications
- Ensure timely audit conduct, reporting, review, and closeout per company SOPs
- Maintain audit records and provide audit status/metrics reports
Study Team Support:
- Serve as CQA Lead for complex programs (including unblinded CQA roles)
- Develop risk mitigation plans; monitor investigator and site/vendor regulatory issues; act as needed
- Guide remediation/corrective action plans
- Lead site inspection preparation; review findings/responses
- Provide GCP training as needed
Quality Systems & QA Support:
- Standardize clinical development activities via SOPs/training; implement CQA quality systems
- Develop/assess GCP metrics and perform trend analyses; drive continuous improvement
- Partner with QA management; support regulatory inspections; other QA duties as assigned
Requirements
- BA/BS in life sciences or related field OR RN + 8+ years relevant industry experience (incl. 4 years CQA in drug development preferred)
- OR Master’s degree + 6+ years relevant experience
- Expert knowledge of FDA clinical trial regulations and ICH GCP; international GCP experience desired
- Audit program leadership for Phase I–IV; strong auditing principles/communication
- Leadership/mentoring, project management, excellent verbal/written skills, strong organization
- Gene therapy clinical trial experience preferred
Compensation & Benefits
- Base salary: $148,500–$203,000; annual bonus target 30% of earned base; equity long-term incentive eligibility
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage.
Responsible for driving and leading Clinical Quality Assurance (CQA) activities supporting research and development/commercial products across multiple therapeutic areas. Provides QA expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
Your Contributions
Good Clinical Practice (GCP) Audit Management:
- Lead, plan, conduct, and oversee GCP audits (vendor, investigator sites, internal)
- Develop and execute audit plans; oversee consultant auditors; manage stakeholder communications
- Ensure timely audit conduct, reporting, review, and closeout per company SOPs
- Maintain audit records and provide audit status/metrics reports
Study Team Support:
- Serve as CQA Lead for complex programs (including unblinded CQA roles)
- Develop risk mitigation plans; monitor investigator and site/vendor regulatory issues; act as needed
- Guide remediation/corrective action plans
- Lead site inspection preparation; review findings/responses
- Provide GCP training as needed
Quality Systems & QA Support:
- Standardize clinical development activities via SOPs/training; implement CQA quality systems
- Develop/assess GCP metrics and perform trend analyses; drive continuous improvement
- Partner with QA management; support regulatory inspections; other QA duties as assigned
Requirements
- BA/BS in life sciences or related field OR RN + 8+ years relevant industry experience (incl. 4 years CQA in drug development preferred)
- OR Master’s degree + 6+ years relevant experience
- Expert knowledge of FDA clinical trial regulations and ICH GCP; international GCP experience desired
- Audit program leadership for Phase I–IV; strong auditing principles/communication
- Leadership/mentoring, project management, excellent verbal/written skills, strong organization
- Gene therapy clinical trial experience preferred
Compensation & Benefits
- Base salary: $148,500–$203,000; annual bonus target 30% of earned base; equity long-term incentive eligibility
- Retirement match, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage.