What are the responsibilities and job description for the Senior GCP Quality Assurance Auditor position at MDA Edge?
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:
Must-Haves:
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.
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.
- Experience working in biopharma companies focused on neurology or psychiatry.
- Understanding of audit strategy for complex clinical studies and vendors.
- Work Schedule: Hybrid (3 days onsite in Paramus, NJ)
- Travel: Up to 10%
- Soft Skills: Strong communicator, detail-oriented, and comfortable managing multiple stakeholders.
Salary : $48
