Validation Lead, Quality Assurance

Validation Lead, Quality Assurance

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.

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 Lead, Quality Assurance opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA (Onsite).

Purpose :

The Validation Lead, Quality Assurance, is an individual contributor role 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 Lead will be a leader and SME accountable for validation strategy, and managing validation projects. 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 Lead 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 Quality Assurance areas and will work closely with counterparts in the Manufacturing, Quality Control, Materials Management, Engineering, and Cytogenomics 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 :

• 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.
• Lead and mentor validation staff, providing guidance in support of the continuous improvement, monitoring, and sustaining validation practices and records.
• 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 ensures 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 development of compliant validation processes and procedures to satisfy existing and new compliance requirements and supports improvement of existing work practices.