Director of Validation

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.