CQV Manager

We are seeking an accomplished and highly experienced CQV Manager to lead and oversee all Commissioning, Qualification, and Validation activities within our organization. The ideal candidate will have more than 15 years of proven leadership and technical expertise in CQV, preferably within the pharmaceutical, biotechnology, or related regulated industries.

• Develop, implement, and manage CQV strategies and protocols for new and existing facilities, equipment, utilities, and processes.
• Lead large-scale projects, including greenfield and brownfield facility startups, expansions, or technology transfers.
• Provide hands-on leadership and mentorship to CQV teams, ensuring alignment with regulatory, company, and project requirements.
• Oversee risk assessment, protocol generation, execution, and approval aligned with GMP, GAMP, and other applicable standards.
• Foster cross-functional collaboration with engineering, production, quality, and project management teams to ensure proper integration of CQV processes.
• Monitor and control project budgets, resources, and schedules related to CQV.
• Act as a primary contact for regulatory inspections, customer audits, and internal reviews related to CQV activities.
• Drive continuous improvement initiatives, staying current with technological, regulatory, and industry best practices.
• Prepare, review, and approve documentation (URS, DQ, IQ, OQ, PQ, SOPs, master plans, reports).
• Troubleshoot complex validation and qualification issues, providing expert guidance and resolution pathways.
• Ensure data integrity, compliance, and robust documentation throughout CQV lifecycle.

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
• 15+ years of direct experience in CQV, including significant leadership roles in regulated industries.
• Deep understanding of GMP, FDA, EMA, GAMP, and relevant global regulatory standards.
• Extensive hands-on experience with commissioning and qualification of facilities, equipment, and utilities (HVAC, CIP/SIP, Autoclaves, Water Systems, Process Equipment, etc.).
• Proven track record managing multiple projects and teams across complex organizations.
• Strong communication, negotiation, and stakeholder management skills.
• High proficiency in CQV project management tools, quality systems, and digital documentation.
• Experience preparing for and leading regulatory and client audits. xcfaprz
• Certification(s) in CQV or validation (preferred).