Sr. Clinical QA Manager
$148.5k - $203kQualStaff Resources | San Diego Staffing | Employment Recruitment Company
Sr. Clinical QA Manager - Pharmaceutical Industry
QUICK FACTS
The company is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws.
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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.
The company is an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws.
#LI-JL1
Vacancy posted 1 day ago
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