Contractor GCP Auditor
Rqteam is hiring a remote Contractor GCP Auditor. The career level for this job opening is Experienced and is accepting USA based applicants remotely. Read complete job description before applying.
Rqteam
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Job Details
RQM+ is a leading MedTech service provider with a large global team of regulatory and quality experts. We provide comprehensive clinical trial, lab, and reimbursement services, reducing risk and supporting market access for medical devices, digital therapeutics, and diagnostics.
Primary Responsibilities:
- Project management, audit planning, and execution within timelines.
- Issuing audit reports and securing final approval.
- Providing client support (80% auditor, 20% mentor).
- Identifying opportunities for additional RQM+ support and feeding back to business development.
- Supporting junior auditor training and development.
- Maintaining training on new/revised regulations, standards, and guidances.
- Arranging and hosting client meetings, conducting audits with confidence and quiet authority.
- Managing challenging situations and difficult conversations with tact, diplomacy, and integrity.
Requirements:
- Professional and qualified Medical Device lead auditor with 10+ years of experience in the Clinical Research (Medical Device) industry.
- Expertise in Good Clinical Practice (21 CFR, ISO14155, ICH GCP).
- FDA BIMO Audit expectations (highly desirable)
- ISO20916 and EU IVDR (highly desirable)
- Robust auditing experience.
- University degree or equivalent in science or nursing.
Behaviors:
- High integrity
- Laser-focused on customer success
- Continuous improvement
- Effective and proactive communication
- Courageous, proactive problem-solving
- Teamwork and enjoyment
- Thoughtful solutions for concerns
- Treat others as you want to be treated