Manager Quality Validation

Guerbet is seeking an experienced Validation Manager to lead validation activities supporting our pharmaceutical manufacturing operations. This role provides technical and people leadership for the Validation team while ensuring facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning processes, and laboratory systems remain compliant with applicable regulatory and quality requirements.

As a key Validation subject matter expert, you will oversee the complete validation lifecycle
, including qualification, validation, requalification, and revalidation programs. You will partner closely with Engineering, Manufacturing Science & Technology (MS&T), Operations, Quality Assurance, Regulatory Affairs, and other site teams to support manufacturing operations, capital projects, new product introductions, and continuous improvement.

The ideal candidate combines deep technical validation expertise with strong leadership skills and significant experience within cGMP pharmaceutical manufacturing, particularly parenteral or injectable operations
.

• Lead the day-to-day activities of the Validation department, including internal employees, specialists, and external validation contractors.
• Establish team priorities, assignments, objectives, and schedules to ensure validation activities are executed accurately, efficiently, and on time.
• Coach, mentor, and develop Validation team members while building strong technical capabilities across the function.
• Manage departmental resources and support performance management, workload planning, and development of team objectives.
• Serve as a site Validation subject matter expert (SME) and provide technical guidance to project teams and senior stakeholders.
• Effectively communicate validation risks, project status, resource needs, and recommendations to site leadership.

• Provide leadership and technical oversight for validation and qualification activities involving:
• Manufacturing and laboratory equipment
• Facilities and classified areas
• Computerized systems
• Manufacturing processes
• Cleaning processes
• Process validation
• Oversee the development, execution, review, and approval of IQ/OQ/PQ protocols and reports
  .
• Ensure validation documentation is complete, technically sound, scientifically justified, and compliant with applicable requirements.
• Lead and maintain the site's revalidation and requalification program
  .
• Apply risk-based validation approaches to establish robust and defendable validation strategies.
• Review and assess change controls to determine validation impact and appropriate qualification or revalidation requirements.

• Own and continuously improve the site's Validation Master Plan (VMP).
• Develop, maintain, and improve validation policies, procedures, standards, and supporting systems.
• Ensure validation activities comply with applicable cGMP/cGxP requirements and global regulatory expectations
  .
• Support internal audits, regulatory inspections, agency audits, and vendor audits as a Validation SME.
• Review deviations, change controls, risk assessments, CAPAs, and related GMP documentation for validation impact.
• Partner with Quality to identify validation-related quality issues and establish appropriate corrective and preventive actions.
• Maintain inspection readiness and ensure validation documentation supports regulatory expectations.

• Lead validation strategy and execution for large-scale capital projects
  , including projects requiring multiple qualification protocols and comprehensive validation plans.
• Support equipment commissioning and qualification activities associated with new or modified pharmaceutical manufacturing systems.
• Provide Validation…