Job Description

The CQV Manager is a senior leadership role responsible for directing commissioning, qualification, and validation (CQV) activities across capital projects, facility expansions, equipment installations, and process improvement initiatives in a GMP-regulated manufacturing environment. The role leads CQV strategy, planning, and execution so that facilities, utilities, equipment, and computerized systems are delivered on schedule, within budget, and in compliance with regulatory expectations. As the primary CQV subject matter expert, the Manager partners with Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs to maintain validated states and inspection readiness. The role also provides technical guidance and mentorship to CQV engineers and validation specialists, and reports project status to senior management and site leadership. This position is primarily based in Japan (Yamagata Prefecture) and will support site operations and strategic projects across the organization's manufacturing network.

Key Responsibilities

• Lead end-to-end CQV activities for capital projects, facility expansions, equipment installations, and process improvement initiatives.
• Develop and execute CQV strategies aligned with project timelines, quality requirements, and regulatory expectations.
• Establish commissioning and qualification plans covering facilities, utilities, equipment, and computerized systems.
• Manage CQV project schedules, milestones, budgets, resources, and risk assessments.
• Coordinate internal and external CQV resources, including engineering contractors and validation consultants.
• Oversee preparation, review, and approval of Validation Master Plans (VMP), Commissioning Plans, DQ, IQ, OQ, and PQ protocols, Traceability Matrices, Risk Assessments, and Validation Summary Reports.
• Ensure qualification activities comply with GMP requirements, EU GMP Annex 15, PIC/S Guidelines, ICH Q8, Q9, and Q10, FDA 21 CFR Parts 210 & 211, and GAMP 5 principles.
• Lead CQV activities for facilities and utility systems, including HVAC, cleanrooms and controlled environments, water systems (PW/WFI), clean steam, compressed air and process gases, and environmental monitoring systems.
• Lead CQV activities for process, packaging, and laboratory equipment, as well as Building Management Systems (BMS), Manufacturing Execution Systems (MES), and SCADA/PLC-controlled systems.
• Ensure inspection readiness for internal audits, regulatory inspections, and customer audits.
• Support investigations, deviations, CAPAs, and change controls related to validated systems.
• Partner with Quality Assurance, Engineering, Manufacturing, and Regulatory Affairs to maintain validated states.
• Drive continuous improvement initiatives for validation lifecycle management.
• Act as the primary CQV subject matter expert for project teams and site leadership.
• Collaborate with global engineering and quality teams to harmonize validation approaches.
• Provide technical guidance and mentorship to CQV engineers and validation specialists.
• Facilitate project meetings and communicate project status to senior management.

Required Qualifications

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related discipline.
• Master's degree is advantageous.
• Minimum 8-12 years of experience in pharmaceutical, biotechnology, vaccine, or medical device manufacturing environments.
• Minimum 3-5 years of leadership or project management experience overseeing CQV or validation teams.
• Proven experience supporting large-scale GMP facilities, capital projects, or site expansions.
• Strong knowledge of lifecycle validation and risk-based qualification methodologies.

Why join us?

• Generous Leave Policy.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.