Senior GCP Quality Assurance Auditor

MDA Edge; Paramus (NJ); Hybrid; USD 80,000 - 100,000; Full time

Job summary

Join a dynamic biopharma company as a Senior GCP Quality Assurance Auditor, where you'll lead global GXP audits and ensure clinical trials meet the highest quality standards. This role offers a unique opportunity to collaborate with cross-functional teams and drive continuous improvement projects. If you have a strong background in GCP and regulatory compliance, and you're looking to make a significant impact in a fast-growing industry, this is the perfect position for you. Enjoy a hybrid work schedule and the chance to contribute to groundbreaking neurology and psychiatry therapies.

Qualifications

• 5+ years of experience in the pharmaceutical industry.
• Strong background in GCP and pharmacovigilance audits.

Responsibilities

• Lead and participate in global GXP audits.
• Prepare detailed audit reports and track non-conformances.

Skills

GCP Audits

Pharmacovigilance

Regulatory Compliance

Clinical Systems (IRT, EDC)

Audit Reporting

Education

Bachelor's degree in a scientific or healthcare field

Tools

Clinical Systems (IRT, EDC)

Job description

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This range is provided by MDA Edge. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$48.00/hr - $48.00/hr

Industry: Biopharma – Neurology & Psychiatry Therapies
Are you an experienced GCP professional looking to make an impact in a fast-growing biopharma company? Join our team as a Senior GCP Quality Assurance Auditor and help ensure our clinical trials meet the highest standards for quality and compliance. What You'll Do:

• Lead and participate in global GXP audits — including internal teams, CROs, CMOs, investigator sites, and other clinical vendors.
• Conduct audits on clinical processes and systems like IRT and EDC.
• Prepare detailed audit reports and track non-conformances.
• Support regulatory inspections and help drive continuous improvement projects.
• Collaborate with cross-functional teams including clinical operations, vendor management, and QA consultants.
• Stay current with global regulatory guidelines (FDA, EMA, ICH GCP) and help apply them to our processes.

What We're Looking For:
Must-Haves:

• Bachelor's degree in a scientific or healthcare field.
• 5+ years of experience in the pharmaceutical industry.
• Strong background in GCP and pharmacovigilance audits.
• Experience with both internal and external audits.
• Familiarity with clinical systems (e.g., IRT, EDC).
• Solid knowledge of SOPs, QMS, and regulatory compliance.

Nice-to-Haves:

• Experience working in biopharma companies focused on neurology or psychiatry.
• Understanding of audit strategy for complex clinical studies and vendors.

Additional Details:

• Work Schedule: Hybrid (3 days onsite in Paramus, NJ)
• Travel: Up to 10%
• Soft Skills: Strong communicator, detail-oriented, and comfortable managing multiple stakeholders.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  IT Services and IT Consulting

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