Senior Validation Specialist, 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. 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 heath 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 Senior Validation Specialist, Quality Assurance opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

The Validation Specialist, Quality Assurance, will provide QA oversight of commissioning, qualification and validation support to M-TC's cGMP Cell Therapy Manufacturing facility as the products move through clinical trials and commercialization. This position is responsible for scientifically sound, documented evidence that our systems and processes will perform as required to standards set forth by Quality Assurance, internal clients and global regulatory bodies. The Validation Specialist 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, and Materials Management teams to help ensure high quality standards and value delivery for our patients.

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

• Individual Contributor responsible to execute QA Validation Strategy for clinical and pre-commercial cell and gene therapy manufacturing facility.


• Responsible for equipment and facility validation. Validation work may also include the following areas based on experience:
  
  
  
  • Process Validation/PPQ
  
  
  • Aseptic Process Simulation Validation
  
  
  • Analytical Equipment Qualification/Validation
  
  
  • Analytical Method Validation
  
  
  
  


• Authors and/or approves technical documents such as validation protocols, reports, user requirements statements, deviations and risk assessments etc. Writes, executes and approves validation protocols and reports following good documentation practices.
  
  
  
  • 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 products.
  
  
  • Evaluate vendor qualification packages and create supplemental protocols as necessary.
  
  
  
  


• SME for 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.


• Performs periodic review of equipment and systems.


• Develops 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.


• Develops compliant validation processes and procedures to satisfy existing and new compliance requirements and leads improvement of existing work practices.