Senior Manager, Clinical Quality Assurance

Astrix; Princeton (NJ); On-site; USD 90,000 - 124,000; Full time

Benefits offered by this job

Benefits included

Job summary

Astrix, a biotechnology research company focused on cardiovascular drug development, seeks Senior Manager/Associate Director, Clinical Quality in Princeton, NJ. This hands-on role provides GCP quality oversight, risk management, audits, and regulatory guidance.

You will collaborate with Clinical Operations and cross-functional teams to ensure GCP compliance, drive CAPA, QMS improvements, and inspections readiness, while advancing medicines that deliver meaningful outcomes for patients.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Senior Manager: 8+ years of pharmaceutical or biotechnology industry experience, including 5+ years of GCP Quality Assurance experience.
• Strong knowledge of GCP Quality Management Systems, clinical trials, and drug development.
• Hands-on experience conducting clinical systems/process audits, clinical investigator site audits, and clinical vendor audits.
• Experience developing and maintaining SOPs.
• Strong understanding of FDA, ICH, and GCP regulations and guidelines; GLP/GVP experience is a plus.
• Expertise in CAPA, root cause analysis, risk management, and quality oversight.
• Excellent communication, collaboration, organization, and problem-solving skills.
• Ability to work independently, manage priorities, and effectively collaborate with cross-functional stakeholders.

Responsibilities

• Provide quality oversight for clinical studies, including protocol deviations, risk assessments, participant safety, and data integrity.
• Partner with Clinical Development, Clinical Operations, and study teams to ensure GCP compliance.
• Conduct and support internal and external GxP audits, including clinical investigator and vendor audits.
• Support audit and regulatory inspection readiness, including CAPA development and inspection activities.
• Support the Quality Management System (QMS), including CAPAs, deviations, change control, risk management, quality complaints, and quality metrics.
• Monitor, trend, and assess GxP non-conformances, protocol deviations, and CAPAs.
• Interpret and apply FDA, ICH, GCP, GLP, and GVP regulations and guidelines.
• Review and contribute to the development and maintenance of SOPs, policies, and quality standards.
• Collaborate cross-functionally to promote a strong culture of quality and compliance across R&D.

Skills

GCP QA

Audits & Inspections

Regulatory Guidance

CAPA & Root Cause

Cross-functional

SOPs Development

Education

Bachelor’s in Science

Job description

Pay Rate Low: 65 | Pay Rate High: 90

Our client is an innovative biotechnology research company focused on cardiovascular drug development, dedicated to advancing medicines that go beyond symptom management to help deliver meaningful, functional outcomes for patients.

Title

Senior Manager/Associate Director, Clinical Quality

Location

Princeton, NJ

Schedule

Hybrid – Minimum 2 days onsite per week (If perm, 4 days onsite required)

Pay Rate

$65–$90/hour, with flexibility for the right candidate (benefits included)

Duration

6–12 month contract with potential for hire

Position Overview

This is a hands-on role providing GCP quality oversight, risk management, audit and inspection support, and regulatory guidance while partnering closely with Clinical Operations and cross-functional teams.

Key Responsibilities

• Provide quality oversight for clinical studies, including protocol deviations, risk assessments, participant safety, and data integrity.
• Partner with Clinical Development, Clinical Operations, and study teams to ensure GCP compliance.
• Conduct and support internal and external GxP audits, including clinical investigator and vendor audits.
• Support audit and regulatory inspection readiness, including CAPA development and inspection activities.
• Support the Quality Management System (QMS), including CAPAs, deviations, change control, risk management, quality complaints, and quality metrics.
• Monitor, trend, and assess GxP non-conformances, protocol deviations, and CAPAs.
• Interpret and apply FDA, ICH, GCP, GLP, and GVP regulations and guidelines.
• Review and contribute to the development and maintenance of SOPs, policies, and quality standards.
• Collaborate cross-functionally to promote a strong culture of quality and compliance across R&D.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Senior Manager: 8+ years of pharmaceutical or biotechnology industry experience, including 5+ years of GCP Quality Assurance experience.
• Strong knowledge of GCP Quality Management Systems, clinical trials, and drug development.
• Hands‑on experience conducting clinical systems/process audits, clinical investigator site audits, and clinical vendor audits.
• Experience developing and maintaining SOPs.
• Strong understanding of FDA, ICH, and GCP regulations and guidelines; GLP/GVP experience is a plus.
• Expertise in CAPA, root cause analysis, risk management, and quality oversight.
• Excellent communication, collaboration, organization, and problem‑solving skills.
• Ability to work independently, manage priorities, and effectively collaborate with cross‑functional stakeholders.

Preferred Qualifications

• Cardiovascular therapeutic area experience is a plus.
• Strong Phase II and Phase III clinical trial experience preferred.
• GLP and/or Phase I experience is a plus.
• Experience supporting regulatory inspections and global clinical development.
• Willingness to work onsite to support cross‑functional collaboration, audits, and inspections.

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