Quality Assurance Manager – Clinical

This is a fully remote position, open to applicants in California.

📋 Description

• Compose, modify, and assess Standard Operating Procedures (SOPs), policies, operational practices, investigation reports, and quality metric trend analyses.

• Execute audits and uphold Annual Audit Plans for internal departments, Contract Research Organizations (CROs), specialized service providers, and clinical trials.

• Co-facilitate FDA and regulatory inspections.

• Oversee the organization-wide electronic Quality Management System (eQMS) encompassing Document Control, Training, Deviations, Complaints, and Corrective and Preventive Actions (CAPAs).

• Supervise Computer System Validation (CSV) and Change Control Management processes.

• Assess non-conformance scenarios, analyze root causes and corrective measures, and ensure prompt resolution.

• Serve as the appointed QA Representative for clinical studies regarding Protocol Deviation Reviews and Risk Management.

• Create quality indicators and metrics to evaluate system efficiency.

• Conduct Good Clinical Practice (GCP) training sessions for both internal staff and contract personnel.

⛳️ Requirements

• Bachelor’s degree or higher in science, nursing, or a related health sciences field.

• Over 8 years of experience in the pharmaceutical, biopharmaceutical, or clinical quality sectors.

• In-depth understanding of FDA regulations and ICH-GCP guidelines.

• Knowledge of global regulatory standards and 21 CFR Part 11 requirements is preferred.

• Willingness to travel approximately 25% of the time, mainly for essential vendor or site audits.

• CQA (Certified Quality Auditor) or RQAP-GxP certification is highly desirable.

🏝️ Benefits

• Competitive salary package.

• Fully remote work environment.

• 401K plan.

• Paid Time Off (PTO).

• Health insurance coverage.

• Vision insurance coverage.

• Dental insurance coverage.

• Resources and infrastructure to foster your success.