What are the responsibilities and job description for the Senior GCP Quality Assurance Auditor position at Macpower Digital Assets Edge Private Limited?
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.
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:
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.
