Validation Manager

Validation Manager

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The Validation Manager will lead 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/ MA-TC's cGMP Cell Therapy Manufacturing facility in Westborough, MA as products move through clinical trials and commercialization. The Validation Manager will be a leader and SME accountable for capital project oversight for validation, determining and leading validation strategy, and managing validation project teams. The candidate will be responsible for oversight of qualification and validation procedures and practices in accordance with global regulatory bodies (FDA, EMA, ICH, Japan guidance), Astellas policies and procedures and industry best practices. The Validation Manager will ensure that all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across a broad range of areas and will work closely with counterparts in the Manufacturing, Quality Control, Materials Management, Engineering, Cytogenomics, and Quality Assurance teams to ensure high quality standards and value delivery for our patients.

Role and Responsibilities

Essential Duties and Responsibilities include, but are not limited to, the following:

• 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 ValSuite dataloggers 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.