Sr. Clinical QA Manager
Neurocrine Biosciences
August 13, 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 in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance (QA) expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
Your Contributions (include, But Are Not Limited To)
GCP Audit Management:
- Lead, plan, conduct, and oversee GCP audits (vendor, clinical investigator site, internal) to ensure compliance with GCP/regulatory requirements, study protocols, monitoring plans, and policies.
- Develop and execute audit plans; oversee audit resourcing/consultant auditors; communicate with stakeholders; assist with audit site selection; ensure timely audit reporting/review/closeout per SOPs.
- Maintain audit records/schedules/files and audit database/tracker.
- Provide proactive audit status and metrics reports to management.
Study Team Support:
- Serve as the CQA Lead for complex programs (including unblinded CQA roles).
- Develop risk mitigation plans; monitor investigator and study/site/vendor regulatory status for GCP risks and act as needed.
- Guide remediation and corrective action plans; prepare for site inspections and review findings/responses with QA management.
- Provide GCP training as needed (including Investigator Meeting training).
Quality Systems:
- Standardize clinical development activities via SOPs and personnel training; implement quality systems/processes.
- Develop/assess GCP metrics and perform trend analyses for management reporting.
- Identify improvement areas and collaborate on continuous improvement.
QA Department Support:
- Partner with QA management on compliance strategy; lead QA initiatives as assigned.
- Support on-site regulatory inspections.
Requirements:
- BA/BS in life sciences (or related) or RN + 8+ years industry experience (4 years CQA in drug development preferred). OR Master’s + 6+ years.
- Expertise in FDA clinical trial regulations and ICH Guidelines; international GCP experience desired.
- Experience creating comprehensive audit programs and conducting Phase I-IV audits of investigator sites and vendors; strong auditing principles/communication.
- Strong leadership, mentoring, project management, computer, communications, problem-solving, analytical skills.
- Ability to lead multiple teams, meet multiple deadlines, and follow-through on corrective actions.
- Gene therapy clinical trial experience preferred.
Benefits (explicitly stated):
- Annual base salary: $148,500.00–$203,000.00; annual bonus (target 30%); eligibility for equity long-term incentive program.
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription/dental/vision coverage per plan terms.
Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance (QA) expertise, leadership, and training to ensure adherence with applicable regulatory requirements and company policies/procedures.
Your Contributions (include, But Are Not Limited To)
GCP Audit Management:
- Lead, plan, conduct, and oversee GCP audits (vendor, clinical investigator site, internal) to ensure compliance with GCP/regulatory requirements, study protocols, monitoring plans, and policies.
- Develop and execute audit plans; oversee audit resourcing/consultant auditors; communicate with stakeholders; assist with audit site selection; ensure timely audit reporting/review/closeout per SOPs.
- Maintain audit records/schedules/files and audit database/tracker.
- Provide proactive audit status and metrics reports to management.
Study Team Support:
- Serve as the CQA Lead for complex programs (including unblinded CQA roles).
- Develop risk mitigation plans; monitor investigator and study/site/vendor regulatory status for GCP risks and act as needed.
- Guide remediation and corrective action plans; prepare for site inspections and review findings/responses with QA management.
- Provide GCP training as needed (including Investigator Meeting training).
Quality Systems:
- Standardize clinical development activities via SOPs and personnel training; implement quality systems/processes.
- Develop/assess GCP metrics and perform trend analyses for management reporting.
- Identify improvement areas and collaborate on continuous improvement.
QA Department Support:
- Partner with QA management on compliance strategy; lead QA initiatives as assigned.
- Support on-site regulatory inspections.
Requirements:
- BA/BS in life sciences (or related) or RN + 8+ years industry experience (4 years CQA in drug development preferred). OR Master’s + 6+ years.
- Expertise in FDA clinical trial regulations and ICH Guidelines; international GCP experience desired.
- Experience creating comprehensive audit programs and conducting Phase I-IV audits of investigator sites and vendors; strong auditing principles/communication.
- Strong leadership, mentoring, project management, computer, communications, problem-solving, analytical skills.
- Ability to lead multiple teams, meet multiple deadlines, and follow-through on corrective actions.
- Gene therapy clinical trial experience preferred.
Benefits (explicitly stated):
- Annual base salary: $148,500.00–$203,000.00; annual bonus (target 30%); eligibility for equity long-term incentive program.
- Retirement savings plan (company match), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription/dental/vision coverage per plan terms.