Senior QA Compliance Lead - GMP & Regulatory Expert

Guerbet; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet in Raleigh, NC is seeking a Principal QA Compliance professional to provide leadership and SME guidance across regulatory and quality systems. You will partner with Operations, Manufacturing & Development, Engineering and QA to sustain GMP compliance and drive continuous improvement.

You will lead regulatory inspections, manage CAPAs and APQRs, and mentor Quality Engineers, shaping a culture of quality excellence across the site.

Qualifications

• Bachelor’s degree in Life Sciences, Business, or related field; master’s preferred.
• 8–12 years of experience within the pharmaceutical industry in QA, Quality Compliance, Quality Systems, or GMP-regulated function.
• Experience with deviations/exceptions, CAPAs, complaints, investigations, root cause analysis, APQRs, quality metrics, and regulatory inspections.
• ASQ Certification (Inspector/Auditor) preferred.
• Strong GMP and regulatory compliance knowledge; excellent writing and documentation skills.

Responsibilities

• Lead regulatory inspections and act as SME or Inspection Room Representative.
• Develop inspection responses and ensure regulatory commitments are met on schedule.
• Monitor quality metrics and trends, including Cost of Poor Quality and KPIs.
• Prepare APQRs and identify meaningful trends and CAPA needs.
• Approve or review complaints, deviations, CAPAs, investigations, and related docs.
• Conduct investigations within QA/compliance systems when required.
• Lead Kaizen and continuous improvement initiatives across the site.
• Support GMP training and onboarding.
• Supervise Quality Engineers when needed; collaborate across functions to strengthen systems.

Skills

Leadership

SME

Regulatory inspections

Quality metrics

CAPAs

Data trend analysis

GMP compliance

Continuous improvement

Documentation

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences, Business, or related field

Master’s degree preferred

ASQ Certification preferred

Tools

Microsoft Office

Job description

Guerbet in Raleigh, NC is seeking a Principal QA Compliance professional to provide leadership and SME guidance across regulatory and quality systems. You will partner with Operations, Manufacturing & Development, Engineering and QA to sustain GMP compliance and drive continuous improvement.

You will lead regulatory inspections, manage CAPAs and APQRs, and mentor Quality Engineers, shaping a culture of quality excellence across the site.