Supplier Quality Specialist

Laboratoire Guerbet•Raleigh, IL

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

Responsibilities

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.