Associate Director – Validation

Job Summary

The Associate Director – Validation is responsible for leading and managing the validation program within the Facilities and Engineering department supporting validation needs site wide, including Site and Project Validation Master Plans, facility and equipment commissioning / qualification / validation (CQV) processes, equipment life cycle validated status assessments, validation documentation packages, and compliance with cGMP regulations within a pharmaceutical organization. This role involves providing expert technical guidance, overseeing complex projects, and ensuring that all systems and processes meet regulatory requirements and support operational efficiency.

Key Responsibilities

• Establish a robust site validation strategy and deploy a comprehensive site validation program that aligns to cGMP industry requirements and global company procedures.
• Collaborate with cross-functional teams, including operations, quality assurance, and quality engineering, to align and drive validation strategy across the site and the global organization via project based and routine assessment activities.
• Owner/architect of long term technical validation direction with focus on systems and processes that support the clinical to commercial validation life cycle.
• Lead validation focused technical teams and provide guidance through execution of facilities and equipment CQV deliverables.
• Lead teams through the development and execution of validation strategies, specification documents, test protocols, and documentation for systems, facilities, equipment, and processes.
• Ensure that all qualification and validation activities meet regulatory requirements (e.g., FDA, EMA) and internal global standards.
• Manage complex validation projects, including elements of asset specification, asset procurement, facility fit planning, and external / internal qualification protocol design, execution, and reporting.
• Oversee the validation review gate assessment as part of the change control and asset induction processes within the asset life cycle program.
• Prepare and review comprehensive documentation for validation within the Enterprise Quality Vault (EQV) and align to global procedures / standards where appropriate.
• Ensure that validation document review cycles are established and drive the implementation of a process for document review and revision.
• Ensure that validation documentation is accurate, complete, and compliant with regulatory requirements.
• Ensure all facilities, systems, and processes comply with regulatory and industry standards with respect to qualification and validation requirements.
• Develop and enforce validation gap assessment and remediation plans.
• Conduct regular internal validation assessment audits and inspections to ensure compliance and address any issues promptly.
• Support internal and external audits as a subject matter expert, formulating technical audit responses and presenting directly to auditors.
• Identify and implement validation process improvements to enhance efficiency, reduce costs, and improve validation program robustness. This may include the implementation of matrix approach practices such as family groups.
• Stay current with industry trends, technological advancements, and regulatory changes to ensure best practices are applied.

Qualifications

• Bachelor’s degree in Engineering, or a related life sciences field; Master’s degree preferred.
• 10-12 years of experience in validation program management, engineering, and capital projects, with significant experience in a pharmaceutical or regulated industry.
• Extensive knowledge of GMP, FDA regulations, and other relevant compliance requirements.
• Proven experience in leading complex validation processes, asset life cycle validated status management, capital engineering projects, and leading technical teams.
• Strong project management skills with experience in budgeting, scheduling, and resource allocation.
• Excellent analytical, problem-solving, and communication skills.
• Ability to manage multiple priorities and work effectively under pressure.

Working Conditions

• Office and on-site facilities environment, with occasional travel to various company sites or off-site locations.
• May require occasional evening or weekend work to address urgent issues or project needs.