Principal Investigator

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

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients.

Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging.

WHAT WE ARE LOOKING FOR

We are seeking an experienced Principal QA Compliance professional to provide leadership and subject matter expertise within our QA Compliance organization.

This highly visible role partners cross-functionally with Operations, Manufacturing & Development, Engineering, Quality Control, and Quality Assurance to maintain a strong state of GMP and regulatory compliance across the site.

As a key Subject Matter Expert (SME), you will provide leadership and guidance across critical quality systems, including deviations/exceptions, CAPAs, complaints, remediation initiatives, investigations, and quality trending. You will also play a key role in regulatory inspections, continuous improvement initiatives, and the development of sustainable quality practices.

The position may provide direct supervision to Quality Engineers and will influence teams across the organization to drive timely, effective, and compliant outcomes.

YOUR ROLE

In this role, you will:

• Serve in a leadership role during regulatory agency inspections and external audits, including acting as an SME or Inspection Room Representative.
• Lead or support the development of inspection responses and ensure regulatory commitments are completed effectively and on schedule.
• Monitor and evaluate quality metrics and trends, including Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, and data trend analysis.
• Support the preparation and completion of Annual Product Quality Reviews (APQRs), identifying meaningful trends, shifts, and potential CAPA requirements.
• Write, review, and provide final approval for complaints, exceptions/deviations, CAPAs, root cause investigations, and related quality documentation.
• Conduct investigations within applicable compliance and quality systems when required.
• Apply strong technical and process knowledge to assess complex quality and compliance issues and develop appropriate solutions.
• Lead Kaizen, brainstorming, and continuous improvement initiatives across the site.
• Support annual and non-routine GMP training.
• Serve as the primary designee for the Quality Operations Manager when needed.
• Proactively maintain compliance with applicable U.S., EU, WHO, Brazilian, and Korean regulatory requirements.
• Provide day-to-day supervision and oversight of Operations Quality Engineers, as applicable.
• Partner across functions to strengthen quality systems, improve processes, mitigate compliance risks, and promote a culture of continuous improvement.

ADDITIONAL RESPONSIBILITIES

• Work in accordance with established safety, environmental, quality, and regulatory requirements and promptly report unsafe conditions or incidents.
• Support information requests from Corporate and other departments.
• Collaborate with corporate teams to advance global continuous improvement, validation, and supplier management programs.
• Support the QA Compliance Manager with special projects and assignments.
• Identify and implement quality assurance best practices that support site and organizational quality objectives.
• Perform other duties as assigned.

YOUR BACKGROUND

Education & Experience

• Bachelor’s degree in Life Sciences, Business, or a related field required; master’s degree preferred.
• 8–12 years of experience within the pharmaceutical industry, with significant experience in Quality Assurance, Quality Compliance, Quality Systems, or a related GMP-regulated function.
• Experience working with deviations/exceptions, CAPAs, complaints, investigations, root cause analysis, APQRs, quality metrics, and regulatory inspections.
• ASQ Certified Quality Inspector, Auditor, or related quality certification preferred.
• Knowledge of microbiology and chemistry is preferred.
• Strong understanding of GMP requirements, pharmaceutical quality systems, and regulatory compliance.
• Strong technical writing and documentation skills, with exceptional attention to detail.
• Demonstrated ability to identify quality risks, process weaknesses, and systemic issues.
• Strong investigation, root cause analysis, and problem-solving capabilities.
• Ability to interpret quality data, recognize trends, and translate findings into appropriate corrective and preventive actions.
• Proven ability to operate effectively in a fast-paced, highly regulated environment while managing multiple priorities.
• Strong organizational skills and sound, consistent decision-making abilities.
• Ability to influence and collaborate effectively with employees and leaders across all levels of the organization.
• Proficiency with Microsoft Office applications.

WORKING RELATIONSHIPS

This position works closely with teams throughout the site, including Operations, Manufacturing & Development, Engineering, Quality Control, and Quality Assurance, as well as corporate teams and external suppliers.

The role requires a high degree of independent judgment and the ability to make sound quality and compliance decisions based on company policies, SOPs, GMP requirements, and applicable regulatory standards.

WHY JOIN US

We offer continued personal development. When you join Guerbet, you:

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 3000 collaborators who are committed every day to offering innovative solutions to improve quality of patients’ life all over the world,
• Are joining a company where we value diversity of talents coming from various horizons.

Do you want to help improve patients’ lives with us?
We look forward to meeting you and continuing our story together!

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is a signatory of the Diversity Charter.
We believe diversity is a source of strength, and all our positions are open to everyone.

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.