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Director of Validation

Cincinnati $180,000 - $240,000 Permanent

Job Responsibilities

  • Lead and maintain the organization’s lifecycle verification and qualification framework to ensure adherence to global regulatory expectations and industry standards. Establish and maintain internal standards, procedures, and governance structures.
  • Oversee financial planning and resource allocation for validation-related activities supporting both development and commercial operations, including infrastructure and expansion initiatives.
  • Build, coach, and develop a high-performing team. Identify capability gaps and implement structured development plans to strengthen technical and compliance competencies.
  • Serve as a quality and technical leader on cross-functional initiatives and governance forums.
  • Provide oversight and quality representation for major infrastructure and expansion programs, ensuring appropriate qualification and risk-based implementation.
  • Establish performance indicators and dashboards to drive operational excellence and continuous improvement.
  • Define and communicate clear team structures, accountabilities, and interfaces across functions and external partners.
  • Conduct performance evaluations for leadership team members, including objective setting and progress tracking.
  • Review and authorize departmental expenditures and capital-related requests in alignment with strategic objectives.
  • Translate enterprise strategy into actionable department plans, ensuring execution aligns with broader organizational priorities.
  • Proactively identify operational or compliance risks, facilitate cross-functional resolution, and escalate critical matters impacting cost, schedule, or regulatory posture.

Job Requirements

  • Bachelor’s degree in a scientific, engineering, or related discipline required.
  • Minimum of 10 years of experience within a regulated life sciences manufacturing environment, including senior-level leadership responsibilities.
  • Demonstrated experience managing teams and developing frontline and mid-level leaders.
  • Strong understanding of regulated quality management frameworks and lifecycle validation methodologies.
  • Comprehensive knowledge of regulatory expectations governing manufacturing, sterile operations, computerized systems, and risk-based qualification approaches.
  • Experience overseeing complex, multi-disciplinary projects with budgetary accountability.
  • Ability to collaborate with executive and cross-functional stakeholders to resolve technical and organizational challenges.
  • Strong verbal and written communication skills with the ability to align teams around strategic objectives.
  • Highly organized with demonstrated analytical and problem-solving capability.
  • Proven ability to independently assess performance, identify improvement opportunities, and implement corrective actions.
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