Director, IT Validation

Role Summary:

The Director of IT validation leads the IT validation efforts ensuring that all IT systems meet regulatory and compliance requirements for both internal and external stakeholders—especially within GXP environments. This role focuses on the development, execution, and management of IT validation strategies and initiatives for systems across the organization. The Director, IT Validation works cross functionally with IT Security, Quality, Regulatory, and Operations teams to ensure the implementation and ongoing compliance of IT systems with FDA, EMA, SOX, and other global regulations.

This role is based in Waltham, MA without the possibility of being a remote role.

Primary Responsibilities Include:

• Lead the development, planning, and execution of IT validation strategies for GxP systems, ensuring compliance with industry standards such as 21 CFR Part 11, GAMP 5, and other relevant regulations
• Oversee the creation and review of validation documentation, including validation plans, protocols (IQ, OQ, PQ) risk assessments, and traceability matrices
• Ensure IT systems are maintained in a validated state throughout their life cycle, including upgrades, patches and decommissioning activities. Collaborate with cross functional teams such (e.g., Quality, Regulatory, IT and Operations) to ensure systems meet business needs and regulatory requirements
• Serve as the subject matter expert on IT Validation—providing guidance and training to protect teams and stakeholders
• Manage and mentor a team of validation engineers and specialists, ensuring best practices are followed
• Lead internal and external audits related to IT validation and compliance, preparing responses and driving corrective actions
• Maintain up-to-date knowledge of global regulatory requirements, validation methodologies, and industry trends, and implement continuous improvement initiatives.
• Partner with vendors and consultants to ensure external systems and applications are validated in accordance with company policies. Provide oversight of validation efforts for cloud-based systems and applications, ensuring compliance with GXP requirements

Education and Skills Requirements:

• A bachelor’s degree in computer science, Information Technology, engineering or related field. Advanced degree preferred
• Minimum of 10 years of experience in IT validation, including three years in a leadership role with GXP regulated environments
• In-depth knowledge of FDA regulations. Including 21 CFR Part 11, GAMP 5 and other relevant global regulatory requirements
• Experience with validation of cloud-based systems and platforms in AWS
• Proven ability to manage multiple validation projects in a fast-paced environment
• Strong leadership skills with experience in mentoring and developing high performing teams
• Excellent verbal and written communication skills with the ability to effectively communicate with stakeholders at all levels of the organization
• Experience in managing validation activities during internal and external audits
• Experience managing evidence Collection and dissemination for assessments and audits
• Excellent analytical and problem-solving skills
• Ability to thrive in a fast-paced and dynamic environment
• Outstanding vendor management skills
• Certification in quality or validation (e.g., ASQ, ISPE) a plus.

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