Quality Assurance Manager – Clinical

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

📋 Description

• Directly report to the Director of Quality.

• Ensure adherence to company policies, procedures, GCP regulations, and relevant guidelines.

• Draft, revise, and assess SOPs, policies, working practices, investigation reports, and quality metric trend analyses.

• Conduct audits and maintain Annual Audit Plans for internal departments, CROs, specialty service providers, and clinical studies.

• Co-facilitate FDA and regulatory inspections.

• Oversee the company-wide electronic Quality Management System (eQMS) for Document Control, Training, Deviations, Complaints, and CAPAs.

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

• Analyze non-conformance instances, assess root causes and corrective measures, and ensure prompt resolution.

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

• Create quality indicators and metrics to evaluate system effectiveness.

• Provide GCP training sessions for both internal and contract personnel.

• Promote a culture of continuous improvement throughout the organization.

⛳️ Requirements

• Bachelor's or advanced degree in science, nursing, or a related health sciences field.

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

• Strong familiarity with FDA regulations and ICH-GCP guidelines.

• Preference for candidates with knowledge of global regulatory guidelines and 21 CFR Part 11 requirements.

• Willingness to travel an average of 25% or less, mainly for necessary vendor or site audits.

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

• Previous experience with CROs is strongly preferred.

🏝️ Benefits

• Corporate benefits.

• Paid time off (PTO).

• Holidays.

• 401(k).

• Health insurance.

• Vision insurance.

• Dental insurance.

• Fully remote work environment.

• Collaborative workplace culture.

• Infrastructure designed to support success.

• Competitive compensation.