Title: Clinical Quality Assurance Specialist | Clinical Audits

Location: Greater Boston Area, MA (Hybrid, 3–5 days onsite)

Employment Type: Contract

Status: Accepting Candidates

About the Role

Join the Clinical Quality team supporting Clinical Quality Assurance (CQA) operations for clinical studies. This role focuses on clinical audits, quality systems, vendor management, and inspection readiness while ensuring compliance with ICH Guidelines, GxP, and global regulatory requirements.

Key Responsibilities
• Support clinical audits, audit reports, audit plans, deviations, and change controls.
• Coordinate audit activities with internal teams and external vendors.
• Assist with quality investigations, issue resolution, and Clinical Quality Operations.
• Support inspection readiness, regulatory inspections, and Clinical Quality meetings.
• Collect and report Clinical Quality metrics and maintain the Clinical Quality Vendor Management database.
• Support training management and onboarding of new employees.

Qualifications
• Bachelor's degree in a Scientific, Quality, Technical, Computer Science, or related discipline.
• 2–5 years of experience in pharmaceutical, CRO, clinical research, or healthcare.
• Knowledge of ICH Guidelines, GxP, FDA, and European regulatory requirements.
• Experience with Clinical Quality Assurance, audits, deviations, investigations, and quality systems.
• Proficiency with Microsoft Word and Excel.
• Experience with Veeva, TrackWise, or ComplianceWire is a plus.

Compensation (MA Pay Transparency):
• Estimated hourly range: $45–$50/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.