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Director Of Validation

Director Of Validation

BioTalentWaltham, MA, United States
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Director of CQV

Introduction

Join a global leader in pharmaceutical manufacturing during a time of rapid growth and investment. We are currently seeking an experienced CQV Director to lead and deliver large-scale commissioning, qualification, and validation (CQV) initiatives, with a strong focus on capital projects , regulatory compliance, and GMP readiness.

This is a high-impact leadership role critical to ensuring operational excellence and regulatory compliance during facility builds, expansions, and major equipment installations.

This Role Will Offer You

  • Leadership of CQV strategy across multi-million-dollar capital projects
  • A collaborative, cross-functional team environment spanning Quality, Engineering, and Manufacturing
  • Influence over GMP site readiness and long-term validation frameworks
  • Competitive salary, bonus structure, and a comprehensive benefits package
  • A chance to shape CQV standards at a growing, innovation-driven organization

You Will Be Responsible For

  • Leading all CQV activities for new facility builds, expansions, and tech transfer projects
  • Developing and executing CQV Master Plans aligned with project timelines and regulatory expectations
  • Managing commissioning and qualification of utilities, cleanrooms, process equipment, and automation systems
  • Overseeing internal and external CQV teams, including engineers and consultants
  • Owning validation protocols (IQ / OQ / PQ), deviation resolution, and change control
  • Ensuring compliance with global regulatory standards : FDA, EMA, ICH, ISPE Baseline Guides, 21 CFR Part 11, GAMP 5
  • Serving as the CQV lead during inspections and audits
  • Partnering with stakeholders across Engineering, QA, Validation, and Project Management

    • You Will Bring the Following

  • 10+ years of CQV experience within regulated pharmaceutical or biotech environments
  • Proven track record of delivering large-scale capital projects ($50M+) from a CQV perspective
  • Strong understanding of validation standards including GAMP 5 , Annex 11 , ASTM E2500 , and 21 CFR Part 11
  • Experience managing cross-functional teams in GMP environments
  • Background in facilities, utilities, and process equipment qualification
  • Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred)
  • Excellent leadership, communication, and project management skills

    • Please feel free to Email me at devon.nzepuome@biotalent.com

    BioTalent Ltd are acting as an employment agency in relation to this opportunity.

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    Director Of Validation • Waltham, MA, United States

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