Validation Manager

Validation Manager

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's health around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Validation Manager opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose :

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.

Essential Job 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.

Manage contracted validation service providers to ensure company requirements are fulfilled through effective performance monitoring and established business agreements.