What are the responsibilities and job description for the Sr. Clinical QA Manager position at QualStaff Resources?
Sr. Clinical QA Manager – Pharmaceutical Industry
QUICK FACTS
QUICK FACTS
- Location: San Diego, CA 92130 - Onsite position
- Pay range: $148,500 - $203,000 annually
- Permanent
- BA/BS in life sciences or related field, RN, or advanced degree
- 6 to 8 years of industry experience in Clinical Quality Assurance
- Requires direct, hands-on Clinical QA (CQA) experience in a sponsor setting
- Strong knowledge of FDA regulations, ICH guidelines, and GCP standards
- Experience with clinical trial audits, vendor audits, and investigator site inspections
- Proven leadership and mentoring skills in a regulatory environment
- Lead Clinical Quality Assurance (CQA) for complex programs, including studies requiring unblinded QA support.
- Build and drive risk mitigation strategies to proactively manage GCP compliance risk.
- Monitor investigator regulatory status and study/site/vendor performance for GCP issues; escalate and intervene as needed.
- Guide remediation and CAPA development to ensure compliant study conduct and documentation.
- Own inspection readiness activities, including preparation support and review of inspection findings/responses with QA leadership.
- Lead GCP audit and quality system activities, including audit planning/oversight, SOP/training support, audit documentation/trackers, and metrics/trend reporting to management.
Salary : $148,500 - $203,000