Supplier Quality Specialist (Raleigh, US)

Guerbet; Raleigh (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Guerbet is seeking a Supplier Quality Specialist to ensure GMP materials meet all quality and regulatory expectations at our Raleigh facility. You will partner with cross-functional teams to drive supplier qualification, audits, CAPA, and change management to safeguard product quality and patient safety.

The role requires a strong background in GMP documentation and risk-based supplier oversight, plus the ability to lead audits and collaborate with Regulatory, Supply Chain, and Manufacturing

Qualifications

• Bachelor’s degree and 5+ years QA in GMP environment.
• Experience authoring and maintaining GMP documents.
• Strong GMP/regulatory knowledge (FDA, EMA, ICH).
• Ability to manage priorities and timelines with attention to detail.

Responsibilities

• Provide ongoing supplier quality oversight for GMP materials.
• Support supplier qualification, re-qualification and lifecycle management.
• Lead supplier audits (remote and on-site) and CAPA follow-up.
• Maintain critical and single-source supplier oversight and risk mitigation.
• Manage supplier change notifications and quality agreements.

Skills

GMP knowledge

QA documentation

Audit experience

Regulatory knowledge

Education

Bachelor's Degree

Job description

Supplier Quality Specialist

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 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

The Supplier Quality Specialist operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Supplier Quality Specialist partners with cross‑functional teams to ensure compliance with GMP documentation throughout the lifecycle of all GMP materials. The Supplier Quality Specialist supports GMP manufacturing through the assessment, enrollment, audit, and surveillance of Suppliers, Service Providers, and Contract facilities for the Raleigh facility.

YOUR ROLE

• Provide ongoing quality oversight of suppliers supporting GMP manufacturing, including raw materials, consumables, external laboratories, and transportation providers.
• Support supplier qualification, re-qualification, and lifecycle management activities using a risk-based approach.
• Support and/or conduct supplier audits (remote and on-site), including audit reporting, CAPA assessment, and follow-up; maintain audit schedule of approved suppliers.
• Maintain oversight of critical and single/sole-source suppliers, including identification of supply and quality risks and development of mitigation strategies.
• Manage supplier change notifications, ensuring appropriate internal documentation, quality risk assessment, and impact analysis in accordance with internal procedures.
• Confirm quality and technical agreements remain current and are not adversely impacted by proposed supplier changes. Also, drafts and manages the creation process of Quality Agreements with new and/or legacy suppliers.
• Provide Supplier Quality impact assessments for internally driven GMP changes and complete assigned change actions.
• Ensure supplier-reported deviations, OOS, and other quality events are logged, assessed, investigated, and closed in accordance with internal procedures.
• Collaborate with cross-functional SMEs to ensure timely investigation, root cause determination, and effective remediation.
• Critically review supplier investigations and CAPAs
• Support supplier and material quality risk assessments, including evaluation of data integrity, traceability, and supply continuity risks.
• Manages the Annual Product Quality Reviews for Technical Quality Agreements and Starting Materials.
• Initiates, manages, monitors and trends the Supplier Corrective Action Reports (SCARs).
• Performs other duties as assigned by management.

YOUR BACKGROUND

Required Qualifications

• Bachelor’s Degree
• 5 years (Specialist) / 8+ (Senior Specialist) years of experience in Quality Assurance in a GMP-regulated environment
• Experience authoring, reviewing, and maintaining controlled GMP documentation
• Strong working knowledge of GMP regulations and regulatory expectations (FDA, EMA, ICH)
• Demonstrated ability to independently manage priorities and timelines
• Exceptional attention to detail

Preferred Qualifications

• ASQ CQA Certification
• Bachelor’s Degree in Life Sciences, Engineering, Quality, or a related discipline
• Advanced expertise in document lifecycle management, change control, deviation support, and CAPA documentation
• Proven experience serving as a subject matter expert for Supplier Quality
• Ability to independently audit new and approved suppliers
• Demonstrated cross‑functional collaboration skills with Supply Chain, Manufacturing, and Regulatory teams
• Technical writing skills, and ability to translate regulatory requirements into clear, user‑focused documentation

Reason to join US

Much more than a Competitive salary,

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 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

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

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]