Sr. Clinical QA Manager – Pharmaceutical Industry QUICK FACTS
Location: San Diego, CA 92130 - Onsite position
Pay range: $148,500 - $203,000 annually
Permanent
EXPERIENCE/EDUCATION YOU WILL NEED
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
MAIN DUTIES OF THE JOB
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.
