Validation Leader - cGMP, QA Systems & Oversight

Guerbet; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Guerbet, a global leader in medical imaging, seeks a senior Validation Lead in the United States to drive validation strategies for manufacturing and laboratory systems. You will manage internal and external teams, coordinate IQ/OQ/PQ activities, and ensure regulatory alignment across FDA/EMEA expectations.

You will partner with Regulatory Affairs, QA and Engineering to advance process improvements, manage risk, and uphold cGMP standards in a dynamic manufacturing environment.

Qualifications

• Must have extensive experience in validation life cycle and protocols (IQ/OQ/PQ).
• Proven ability to lead validation teams and manage internal/external contractors.
• Strong knowledge of cGMP, FDA/EMEA requirements and regulatory expectations.
• Excellent cross-functional communication and problem-solving skills.

Responsibilities

• Lead day-to-day validation activities and ensure on-time completion.
• Coach and supervise Validation staff and contractors.
• Oversee Validation Master Plan and ensure ongoing process improvements.
• Review change controls, risk assessments and GMP documentation for compliance.
• Collaborate with Engineering, MS&T, Operations, QA and Regulatory Affairs.
• Prepare Regulatory Submission Documents for project initiatives.
• Drive initiatives to streamline validation processes and workflows.
• Manage large capital project validation efforts and vendor audits.

Skills

Validation leadership

Project management

Regulatory compliance

cGMP knowledge

Risk assessment

Audits & inspections

Communication

Team leadership

Education

BS degree in engineering or life sciences

Tools

IQ/OQ/PQ tooling

Regulatory submissions tools

Job description

Guerbet, a global leader in medical imaging, seeks a senior Validation Lead in the United States to drive validation strategies for manufacturing and laboratory systems. You will manage internal and external teams, coordinate IQ/OQ/PQ activities, and ensure regulatory alignment across FDA/EMEA expectations.

You will partner with Regulatory Affairs, QA and Engineering to advance process improvements, manage risk, and uphold cGMP standards in a dynamic manufacturing environment.