Quick Overview
Seniority
Mid Senior
Work mode
Hybrid
Location
United States
Posted
23 hours ago
AuditingComplianceRegulatory Compliance
Job Description
Required Skills:
- Bachelor's degree in a life science, engineering, or related technical field.
- 10+ years of experience in quality assurance, regulatory compliance, or auditing in the pharmaceutical, medical device, or combination product industries.
- Proven experience as a lead GxP auditor, including audit program development and execution.
- Deep working knowledge of combination product regulations and drug and device quality system requirements.
- Familiarity with global regulatory frameworks (FDA, EMA, MHRA, Health Canada, PMDA, MFDS, TGA, Medsafe).
- Demonstrated experience developing and delivering training to technical and cross-functional audiences.
- Strong presentation, facilitation, and stakeholder communication skills.
- Able to travel to client sites as required.
Preferred Skills:
- Advanced degree in a relevant discipline.
- Professional certification such as ASQ CQA, CQE, or RAC.
- Experience supporting inspection readiness and regulatory inspections.
- Consulting experience in client-facing, time-and-material engagements.
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