Validation Manager

Validation Manager – Astellas Pharma Institute for Regenerative Medicine (AIRM), Westborough, MA

Join Astellas Pharma, a global biopharmaceutical company focused on developing innovative therapies that transform patient care. AIRM, headquartered in Massachusetts, is advancing stem cell and cell‑therapy medicines for a broad range of indications.

The Validation Manager leads a team responsible for implementing and overseeing validation programs, policies, and procedures related to facilities, utilities, equipment, analytical equipment, cleaning validation, and process performance qualification for AIRM’s cGMP Cell Therapy Manufacturing facility. The role provides capital project oversight, develops validation strategy, manages validation project teams, and ensures compliance with FDA, EMA, ICH, Japan guidance and Astellas policies.

• Manage a team of validation staff, providing guidance in support of continuous improvement, monitoring and sustaining validation practices and records.
• Own validation processes, presenting programs to regulatory inspectors and internal auditors during inspections and internal/partner audits and assist in creation of validation program structure to include strategies, policies, procedures, and master plans.
• Lead recurring validation forums and/or governance teams and manage overarching validation activities and participate in resource planning for capital projects.
• Provide guidance for commissioning and qualification of facilities/utilities, equipment, automated systems, and process validation.
• Author, execute, review and approve validation documentation for facilities/utilities, equipment, automated systems, and process validation and assist with resolving technical issues, evaluating results, and generating reporting documentation.
• Interface with system owners, IT and facilities engineering to ensure all user and compliance requirements are tested as well as support the creation of the requirements for new equipment or systems.
• Authors, executes, and/or approves technical documents such as validation protocols, reports, user requirements, deviations, risk assessments. or products.
• Manage contracted validation service providers to ensure company requirements are fulfilled through effective performance monitoring and established business agreements.
• Evaluate vendor qualification packages and create supplemental protocols as necessary.
• Ensures impact to validation status for new systems and changes to existing systems are performed through science‑based quality risk assessments and adhere to change management policies.
• Ensure data integrity requirements are incorporated in facilities/utilities, equipment, automated systems and process validation activities.
• SME with validation software, such as Ellab Val Suite data loggers to perform mapping studies.
• Maintains close contact with manufacturing, facilities, and laboratory departments to assure effective communication on issues related to validation and the validated state of equipment and endures effective communication on validation issues.
• Accountable for on time delivery of validation deliverables.
• Performs periodic review of equipment and systems.
• Leads development of testing strategies and rationale for equipment/systems.
• Collaborates with cross‑functional stakeholders regarding quality events (e.g., deviations, Corrective / Preventative Actions (CAPAs), etc.), assisting in investigations and ensuring quality records are clearly written, technically sound, and provide thorough root cause analysis and risk assessment.
• Serves as a resource fluent in Global Validation Strategy for the organization, ensuring all steps of the GMP organization remain compliant with Astellas procedures and domestic / international GMP regulations.
• Leads developments of compliant validation processes and procedures to satisfy existing and new compliance requirements and supports improvement of existing work practices.

• BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience within GMP‑regulated industry, or Masters degree with 5+ years of direct validation…