GMP Auditor, QA Compliance
• Remote: East Coast candidates highly preferred
• High travel role to US and EU
Job Summary
This role supports Quality Assurance through cGMP auditing and supplier oversight within a regulated life sciences environment.
Key Responsibilities
• Conduct GMP/GDP audits in alignment with internal and external audit programs
• Support additional GxP audits (e.g., GLP, GCP, GCLP) as needed
• Maintain audit schedules and track findings through resolution
• Manage supplier qualification activities and support Quality Agreements
• Monitor audit metrics, trends, and compliance data
• Assist with regulatory and partner inspections
• Provide QA review support for development documentation as required
• Ensure compliance with applicable FDA, ISO, and ICH regulations
• Contribute to broader QA initiatives as assigned
Qualifications
• Bachelor’s degree or equivalent experience
• 5+ years in an FDA-regulated industry with strong cGMP knowledge
• Certified Quality Auditor (CQA) preferred
• Strong communication skills and attention to detail
• Ability to adapt in a fast-paced environment and collaborate cross-functionally
Apply Now
Apply Now
• High travel role to US and EU
Job Summary
This role supports Quality Assurance through cGMP auditing and supplier oversight within a regulated life sciences environment.
Key Responsibilities
• Conduct GMP/GDP audits in alignment with internal and external audit programs
• Support additional GxP audits (e.g., GLP, GCP, GCLP) as needed
• Maintain audit schedules and track findings through resolution
• Manage supplier qualification activities and support Quality Agreements
• Monitor audit metrics, trends, and compliance data
• Assist with regulatory and partner inspections
• Provide QA review support for development documentation as required
• Ensure compliance with applicable FDA, ISO, and ICH regulations
• Contribute to broader QA initiatives as assigned
Qualifications
• Bachelor’s degree or equivalent experience
• 5+ years in an FDA-regulated industry with strong cGMP knowledge
• Certified Quality Auditor (CQA) preferred
• Strong communication skills and attention to detail
• Ability to adapt in a fast-paced environment and collaborate cross-functionally
Apply Now
Apply Now