Clinical Quality Lead

Astrix Inc.; Princeton (NJ); Hybrid; USD 90,000 - 103,000; Full time

Job summary

Astrix Inc. is seeking a Clinical Quality Lead to drive GCP compliance and quality oversight across clinical development programs in Princeton, NJ. This hands-on role is 80% focused on GCP compliance and 20% on audits and inspections, in a hybrid setting with two onsite days per week.

You will review study documents, support CAPAs, risk management, audits, and vendor assessments, and partner with Clinical Operations to ensure data integrity and regulatory readiness across trials.

Qualifications

• Bachelor’s degree in a scientific field.
• 5+ years of Clinical Quality Assurance (GCP) experience in pharma/biotech.
• Hands-on Phase II/III clinical trial experience.
• Strong knowledge of GCP, FDA, and ICH guidelines.
• Experience with audits, CAPAs, root cause analysis, and risk management.
• Willingness to travel occasionally.

Responsibilities

• Support GCP compliance across studies with Clinical Development.
• Review study documents and plans for compliance.
• Provide quality oversight for trials including safety and data integrity.
• Support audit and inspection readiness.
• Perform internal and external GxP audits.
• Write audit reports and communicate findings.
• Support QMS activities including CAPAs and change controls.
• Track and trend compliance issues and quality events.
• Participate in regulatory inspections and vendor assessments.
• Help develop quality policies, procedures, and SOPs.
• Provide quality training to cross-functional teams.
• Build relationships across R&D to promote quality awareness.

Skills

GCP compliance

Quality oversight

Audit readiness

CAPAs

Root cause analysis

Risk management

Data integrity reviews

Regulatory liaison

Education

Bachelor's degree in a scientific field

Job description

Pay Rate Low: 65.00 | Pay Rate High: 75.00

Clinical Quality Lead

Location: Princeton, NJ (Hybrid, 2 days onsite per week)

Pay Rate: $65-$75/hour

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

About the Role

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.

Key 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 QMSactivities, 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.