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The Director of Commissioning, Qualification, and Validation (CQV) is responsible for leading the site-wide CQV program to ensure facilities, utilities, equipment, computerized systems, manufacturing processes, and laboratory systems are commissioned, qualified, and validated in compliance with current GMP regulations, FDA requirements, EU Annex 1, ICH guidelines, and company quality standards.

This position provides strategic leadership for CQV activities supporting clinical and commercial pharmaceutical manufacturing operations, including aseptic processing, lyophilization, packaging, laboratories, warehousing, and supporting utilities. The Director will build and maintain a sustainable validation lifecycle program while ensuring inspection readiness and operational excellence.

Essential Responsibilities

Strategic Leadership

• Develop and execute the site CQV strategy supporting facility expansion, new product introduction, technology transfers, and commercial operations.
• Establish site validation master plans (VMPs) and long-range CQV roadmaps.
• Provide leadership and oversight for all commissioning, qualification, and validation activities.
• Build and develop a high-performing CQV organization capable of supporting current and future manufacturing needs.
• Serve as the site subject matter expert for validation and qualification requirements.

Facility, Utility, and Equipment Qualification

• Oversee qualification of:
• Cleanrooms and controlled environments
• HVAC systems
• Water systems (PW, WFI)
• Clean steam systems
• Compressed gases
• Environmental monitoring systems
• Manufacturing equipment
• Packaging equipment
• Laboratory instruments
• Warehousing and cold storage systems
• Ensure risk-based qualification approaches are implemented throughout the lifecycle.

Process Validation

• Direct process validation activities in accordance with:
• FDA Process Validation Guidance
• ICH Q8, Q9, and Q10
• EU GMP requirements
• Approve validation protocols and reports.
• Lead continued process verification (CPV) programs.
• Support technology transfer and scale-up activities.

Computer System Validation (CSV/CSA)

• Oversee qualification and validation of computerized systems including:
• MES
• LIMS
• ERP systems
• SCADA systems
• Building management systems
• Environmental monitoring software
• Electronic batch records
• Implement risk-based Computer Software Assurance (CSA) principles.

Project Support

• Partner with Engineering, Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams on capital projects.
• Ensure CQV requirements are integrated into project planning and execution.
• Participate in FAT, SAT, and equipment acceptance activities.
• Support startup and operational readiness activities.

Compliance and Inspection Readiness

• Ensure validation programs remain compliant with:
• FDA cGMP requirements
• EU GMP Annex 1
• ICH guidance documents
• USP standards
• Data Integrity expectations
• Represent the site during regulatory inspections and customer audits.
• Address observations related to validation and qualification activities.

Quality Systems

• Oversee validation-related:
• Change Controls
• Deviations
• CAPAs
• Risk Assessments
• SOPs
• Validation Master Plans
• Ensure validation documentation is maintained in an audit-ready state.

Team Development

• Recruit, train, mentor, and develop CQV professionals.
• Establish performance objectives and succession planning.
• Promote a culture of quality, compliance, accountability, and continuous improvement.

Qualifications

Education

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related scientific discipline required.
• Master’s degree preferred.
• Advanced technical certifications desirable.

Experience

• Minimum 10–15 years of pharmaceutical, biotechnology, or sterile manufacturing experience.
• Minimum 5–8 years of leadership experience managing validation or CQV teams.
• Demonstrated experience supporting FDA, EMA, MHRA, and customer inspections.
• Experience with facility startup, expansion, or greenfield projects strongly preferred.
• Experience in aseptic processing and lyophilized product manufacturing preferred.