Manager Quality Validation

Guerbet; North Carolina; On-site; USD 140,000 - 210,000; Full time

Job summary

Guerbet is seeking an experienced Validation Manager to lead the Validation department within our pharmaceutical manufacturing operations in North Carolina. You will oversee the complete validation lifecycle, including qualification, validation, requalification, and revalidation programs, partnering with Engineering, MS&T, Operations, QA, and Regulatory Affairs to support manufacturing initiatives.

The role requires deep cGMP pharmaceutical knowledge, especially in parenteral or injectable

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related scientific or technical discipline.
• 10+ years of validation experience within a pharmaceutical manufacturing environment.
• Experience leading validation teams, with coaching and development of staff.
• Extensive knowledge of the validation lifecycle and IQ/OQ/PQ methodology.
• Hands-on experience with equipment commissioning and qualification (C&Q), process validation, cleaning validation, and sterilization validation.
• Strong background in parenteral/injectable manufacturing and packaging operations.
• Familiarity with cGMP/cGxP requirements, FDA expectations, ICH guidance, and European regulatory expectations.

Responsibilities

• Lead day-to-day activities of the Validation department, including staff and external contractors.
• Set priorities, assignments, objectives, and schedules for timely validation execution.
• Coach and develop Validation team members, building technical capabilities.
• Manage resources, performance planning, and development of team objectives.
• Serve as site Validation SME and provide technical guidance to project teams and stakeholders.
• Communicate validation risks, project status, and resource needs to site leadership.

Skills

Validation leadership

Team coaching

Project management

IQ/OQ/PQ

cGMP knowledge

Parenteral manufacturing

Risk assessment

Regulatory audits

Lean Six Sigma

Education

Bachelor's degree in Engineering, Life Sciences, or related

Job description

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.

YOUR ROLE

• 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.

Validation & Qualification

• 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.

Validation Program & Compliance

• 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.

Capital Projects & Manufacturing Support

• 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 leadership for new product introductions, process improvements, facility modifications, formulation, filling, and manufacturing initiatives.
• Partner with Engineering, MS&T, Operations, and QA to identify risks, resolve technical challenges, and maintain project timelines.
• Provide Validation input into project scope, resource planning, schedules, and execution strategies.
• Work with Regulatory Affairs to provide validation content and technical documentation supporting regulatory submissions.
• Evaluate validation systems and processes to identify opportunities for increased efficiency, compliance, standardization, and technology improvements.
• Apply Lean, Six Sigma, root cause analysis, risk assessment, and structured problem-solving methodologies where appropriate.
• Lead Operational Excellence initiatives that streamline validation processes while maintaining compliance and scientific rigor.
• Identify and implement improvements that strengthen validation execution and overall site performance.

YOUR BACKGROUND

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related scientific or technical discipline.
• 10+ years of validation experience within a pharmaceutical manufacturing environment.
• Significant experience leading validation teams, including direct supervision, coaching, and development of employees and/or contractors.
• Extensive knowledge of the validation lifecycle and IQ/OQ/PQ methodology.
• Hands-on experience with equipment commissioning and qualification (C&Q), process validation, cleaning validation, and sterilization validation.
• Demonstrated experience supporting pharmaceutical manufacturing equipment, facilities, utilities, and processes.
• Working knowledge of the science and technology associated with parenteral/injectable manufacturing and packaging operations.
• Strong knowledge of cGMP/cGxP requirements, FDA expectations, ICH guidance, and applicable European regulatory expectations.
• Experience evaluating change controls, deviations, risk assessments, CAPAs, and validation documentation.
• Demonstrated experience managing large and complex validation projects.
• Strong troubleshooting, root-cause analysis, and risk assessment/mitigation capabilities.
• Experience supporting regulatory audits and inspections.

Preferred Qualifications

• Experience applying risk-based approaches to validation.
• Experience with computerized systems validation and 21 CFR Part 11.
• Knowledge of 21 CFR Parts 210 and 211 and relevant industry guidance.
• Experience supporting global regulatory expectations and inspections.
• Knowledge of Quality by Design (QbD) principles and relevant ICH guidance.
• Lean or Six Sigma experience, particularly using structured problem solving, statistical analysis, and risk-management tools.
• Experience supporting significant capital projects, site expansions, equipment installations, or manufacturing turnarounds.
• Demonstrated experience improving or modernizing validation programs and systems.