Director, Validation

Role Summary

The Director Validation will lead and oversee the validation activities for our manufacturing processes, equipment, and systems at their respective facility (i.e. Framingham, MA, US or Milton Park, Abingdon, UK). This role is critical to ensuring compliance with regulatory requirements and maintaining the highest standards of quality and safety in our products. This position is based in Framingham and typically has a 5-day on-site expectation.

Responsibilities

• Lead and mentor a team of validation engineers / specialists, fostering a collaborative and innovative work environment while providing guidance, training, and performance management.
• Develop and manage implementation of validation strategies and plans for manufacturing processes, equipment, instrumentation and systems.
• Oversee the development, execution and completion of validation responsibilities required to support site projects / priorities, including timelines, budgets, and resource allocation.
• Ensure all validation activities comply with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GLP, GCP).
• Review, approve and author validation documentation, as necessary, including protocols, reports, discrepancies and SOPs.
• Review proposed changes to validated systems and identify the validation requirements necessary to maintain the system's validated state after execution of the change.
• Collaborate with cross-functional teams, including Quality, Manufacturing, Engineering and R&D, to support validation activities.
• Conduct risk assessments and develop mitigation strategies for validation-related issues.
• Stay current with industry trends and regulatory changes to ensure ongoing compliance and continuous improvement.
• Represent the validation function during regulatory inspections and audits.

Other Responsibilities

• Ensure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.
• Support equipment and process related non-conformance investigations and change control activities.
• Ensure training is kept in GMP compliant state.
• Additional responsibilities as required.

Qualifications

• Education: Bachelor‚Äôs or Master‚Äôs degree in Engineering, Life Sciences, or a related field (Master‚Äôs preferred).
• Required Experience:
  • Minimum 10+ years of experience in validation within the biotechnology or pharmaceutical industry.
  • Excellent knowledge of regulatory requirements, industry standards (FDA, EMA, GMP, USP, ICH) and guidance (ISPE) for multiple validation disciplines preferred.
  • Proven leadership experience with the ability to manage and develop a team.
  • Excellent project management skills, with the ability to handle multiple projects simultaneously.
  • Ability to work collaboratively in a fast-paced, dynamic environment.
  • Experience in inspection/audit presentation and response.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Detail-oriented with a commitment to quality and compliance.

Skills

• Leadership and team development
• Validation strategy development
• Regulatory compliance (FDA, EMA, GMP, GLP, GCP)
• Documentation review and authoring
• Risk assessment and mitigation
• Cross-functional collaboration
• Project management
• Audits and inspections

Education

• Bachelor‚Äôs or Master‚Äôs degree in Engineering, Life Sciences, or a related field (Master‚Äôs preferred)

Additional Requirements

• On-site work at the Framingham, MA location is typical; travel not specified as a typical requirement.