Clinical Quality Lead

About the Role

Location: Princeton, NJ.

Our client is seeking a Clinical Quality Lead to support quality and compliance activities across clinical development programs. This position will work closely with Clinical Operations and study teams to ensure clinical trials follow GCP regulations, company procedures, and industry standards. This is a hands-on quality role with approximately 80% focused on GCP compliance and quality oversight and 20% supporting audits and inspections.

Duration: 6-month contract with high likelihood of extension and possible conversion.

Responsibilities

• Partner with Clinical Development and Clinical Operations teams to support GCP compliance across clinical studies.
• Review study documents, plans, and processes for compliance and quality.
• Provide quality oversight for clinical studies, including protocol deviations, risk assessments, participant safety, and data integrity reviews.
• Support audit and inspection readiness activities.
• Perform internal and external GxP audits.
• Write audit reports and communicate findings to stakeholders.
• Support QMS activities, including CAPAs, Deviations, Risk management, Change controls, Audits and inspections.
• Track and trend compliance issues and quality events.
• Participate in regulatory inspections and vendor assessments.
• Help develop and update quality policies, procedures, and SOPs.
• Provide quality and compliance training to cross-functional teams.
• Build strong working relationships across R&D to promote quality and compliance awareness.

Qualifications

• Bachelor's degree in a scientific field.
• 5+ years of Clinical Quality Assurance (GCP) experience within the pharmaceutical or biotechnology industry.
• Hands-on Phase II and Phase III clinical trial experience.
• Strong knowledge of GCP regulations, FDA requirements, and ICH guidelines.
• Experience supporting clinical trials and clinical quality assurance activities.
• Understanding of drug development and the clinical research environment.
• Experience with audits, inspections, CAPAs, root cause analysis, and risk management.
• Willingness to travel occasionally as needed.

Pay

$65-$75 per hour

Schedule

Hybrid, 2 days onsite per week