Incoming Inspections Lead

Guerbet; Raleigh (NC); On-site; USD 85,000 - 125,000; Full time

Job summary

Guerbet is seeking an Incoming Inspections Lead in Raleigh, NC to ensure raw materials, components, and packaging meet strict specs before release. The role requires deep knowledge of cGMP and regulatory expectations and hands-on leadership of the inspection team.

You will serve as SME for incoming inspections during FDA/EMA audits, coach analysts, and drive continuous improvement across QA, Procurement, Manufacturing and Regulatory Affairs to maintain compliant supply.

Qualifications

• Bachelor’s degree and 5+ years in incoming inspection in cGMP.
• Experience with cGMP, USP, sampling plans and specs.
• Proven investigations, qualification, and supplier issues.
• Strong leadership and cross-functional communication.

Responsibilities

• Leads and owns the incoming inspection program, ensuring materials meet specifications and regulatory requirements prior to release for use.
• Serves as Subject Matter Expert (SME) for incoming inspections during regulatory audits and inspections (e.g., FDA, EMA).
• Provides technical leadership, coaching, and mentorship to incoming inspection analysts and technicians.
• Reviews and approves incoming inspection results, documentation, specifications, and test methods.
• Ensures sampling and testing of raw materials, components, and packaging materials are performed in accordance with SOPs and compendial requirements.
• Establishes and maintains sampling plans, test methods, and acceptance criteria for incoming materials.
• Leads investigations related to incoming material non-conformance, OOS, OOT, or supplier-related quality issues, including root cause analysis and CAPA implementation.
• Drives supplier quality collaboration by supporting material qualification, supplier audits, and change notifications.
• Owns lifecycle management of incoming material specifications, including change control, periodic review, and continuous improvement.
• Ensures laboratory equipment and systems used for incoming inspections are qualified, calibrated, and maintained in an audit-ready state.
• Ensures compliance with cGMP, USP, and internal quality standards, including data integrity (ALCOA+) principles.
• Collaborates cross-functionally with QA, Procurement, Manufacturing, Warehouse, and Regulatory Affairs to support material release and supply chain continuity.
• Leads or contributes to continuous improvement initiatives to enhance inspection efficiency, effectiveness, and compliance.
• Oversees training and ensures competency of personnel performing incoming inspections.
• Performs other duties as assigned by management.

Skills

Leadership

Communication

Problem solving

Cross-functional

Education

Bachelor’s degree or equivalent

Tools

LIMS

SAP ERP

ALCOA+

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 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 Incoming Inspections Lead will be operating 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 Incoming Inspections Lead is responsible for providing technical leadership and oversight of raw material, component, and packaging material inspection activities to ensure compliance with cGMP and quality requirements. This role serves as a Subject Matter Expert (SME) for incoming quality operations, supporting supplier quality, regulatory inspections, and cross-functional collaboration.

YOUR ROLE

• Leads and owns the incoming inspection program, ensuring materials meet specifications and regulatory requirements prior to release for use
• Serves as Subject Matter Expert (SME) for incoming inspections during regulatory audits and inspections (e.g., FDA, EMA), including preparation and response to observations
• Provides technical leadership, coaching, and mentorship to incoming inspection analysts and technicians
• Reviews and approves incoming inspection results, documentation, specifications, and test methods
• Ensures sampling and testing of raw materials, components, and packaging materials are performed in accordance with SOPs and compendial requirements
• Establishes and maintains sampling plans, test methods, and acceptance criteria for incoming materials
• Leads investigations related to incoming material non-conformance, OOS, OOT, or supplier-related quality issues, including root cause analysis and CAPA implementation
• Drives supplier quality collaboration by supporting material qualification, supplier audits, and change notifications
• Owns lifecycle management of incoming material specifications, including change control, periodic review, and continuous improvement
• Ensures laboratory equipment and systems used for incoming inspections are qualified, calibrated, and maintained in an audit-ready state
• Ensures compliance with cGMP, USP, and internal quality standards, including data integrity (ALCOA+) principles
• Collaborates cross-functionally with QA, Procurement, Manufacturing, Warehouse, and Regulatory Affairs to support material release and supply chain continuity
• Leads or contributes to continuous improvement initiatives to enhance inspection efficiency, effectiveness, and compliance
• Oversees training and ensures competency of personnel performing incoming inspections
• Performs other duties as assigned by management.

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree with 5+ years of relevant experience, or equivalent combination of education and experience
• Extensive experience in incoming inspection, raw material testing, or quality control within a cGMP-regulated environment
• Strong knowledge of cGMP, USP requirements, sampling plans (ANSI/ASQ, ISO where applicable), and material specifications
• Proven experience leading investigations, material qualification, and supplier-related quality issues
• Strong leadership, problem-solving, and decision-making skills
• Excellent communication skills with the ability to interact cross-functionally and with suppliers

Preferred Qualifications

• Experience with quality systems such as LIMS, ERP (e.g., SAP), and data integrity requirements (ALCOA+)
• Experience implementing or improving incoming inspection processes, including risk-based sampling strategies or continuous improvement initiatives (e.g., Lean, Six Sigma)
• Prior experience in a lead or supervisory role within a quality or inspection function
• Familiarity with supplier auditing processes, supplier performance monitoring, or external quality partnerships

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+19843443717