Astellas Pharma
Overview
Join to apply for the
Validation Lead, Quality Assurance
role at
Astellas Pharma . 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. Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary focused on stem cell and regenerative medicine therapies. 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, overseeing 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 role ensures that all critical GMP equipment and systems are validated and maintained in compliance with user requirements and regulatory guidelines. The successful candidate will collaborate with Manufacturing, Quality Control, Materials Management, Engineering, and Cytogenomics teams to maintain high quality standards and value delivery for patients. Responsibilities
Own validation processes, presenting programs to regulatory inspectors and internal auditors during inspections and audits; assist in creating validation program structure including strategies, policies, procedures, and master plans. Lead recurring validation forums and governance teams; manage overarching validation activities and 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; assist with resolving technical issues and generating reporting documentation. Interface with system owners, IT and facilities engineering to ensure tests meet user and compliance requirements; support creation of requirements for new equipment or systems. Author, execute, and/or approve technical documents such as validation protocols, reports, user requirements, deviations, risk assessments, or product reports. Manage contracted validation service providers to ensure requirements are fulfilled through performance monitoring and agreements; evaluate vendor qualification packages and create supplemental protocols as necessary. Lead and mentor validation staff; support continuous improvement, monitoring, sustaining validation practices and records. Ensure validation status is updated for new systems and changes via science-based risk assessments and change management policies. Ensure data integrity requirements are incorporated in validation activities for facilities/utilities, equipment, automated systems and processes. Act as SME with validation software (e.g., Ellab ValSuite) for mapping studies. Maintain close contact with manufacturing, facilities, and laboratory departments to ensure effective communication on validation issues and validated state of equipment. Accountable for on-time delivery of validation deliverables. Lead development of testing strategies and rationale for equipment/systems; collaborate with stakeholders on quality events and investigations; ensure quality records are thorough and well-reasoned. Serve as a resource fluent in Global Validation Strategy, ensuring GMP compliance with internal procedures and international regulations. Develop compliant validation processes and procedures to satisfy current and new compliance requirements. Qualifications Required
BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience in GMP-regulated industry, or Master’s degree with 5+ years; or 10+ years of related industry experience in lieu of degree. Strong knowledge of risk-based approaches to commissioning, qualification, and validation in biotech manufacturing. Demonstrated leadership, critical thinking, and ability to influence across the organization to meet milestones. Knowledge of cGMPs for biotechnology; working understanding of ICH Q7, Q8, Q9, Q10 and other regulatory requirements. Ability to interpret regulatory rules and apply Quality-by-Design principles; proficiency in deviation investigations, root cause analysis, CAPA, and risk assessments; proficient in Microsoft Office. Excellent technical writing, and verbal and written communication; ability to work cross-functionally to achieve milestones. Experience interacting with regulatory agencies and providing technical deliverables as a subject matter expert; audit hosting/support. Preferred
Specialized knowledge in niche topics such as bar coding, cell culture, auditing techniques, QC methods, HEPA filtration, etc. Experience with CMO oversight and regulatory compliance considerations. ASQ certifications (e.g., CQE, CQA, CPQ). Experience with electronic document management systems. Working Environment
This position is based in Westborough, MA and requires on-site work. Frequent work in a cleanroom environment. Physical activities including long periods of sitting/standing, lifting up to 20 lbs as needed. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off including Vacation, Sick time, plus holidays 401(k) match and company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Incentives for eligible positions Long Term Incentive Plan for eligible positions EOE including Disability/Protected Veterans
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Join to apply for the
Validation Lead, Quality Assurance
role at
Astellas Pharma . 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. Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary focused on stem cell and regenerative medicine therapies. 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, overseeing 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 role ensures that all critical GMP equipment and systems are validated and maintained in compliance with user requirements and regulatory guidelines. The successful candidate will collaborate with Manufacturing, Quality Control, Materials Management, Engineering, and Cytogenomics teams to maintain high quality standards and value delivery for patients. Responsibilities
Own validation processes, presenting programs to regulatory inspectors and internal auditors during inspections and audits; assist in creating validation program structure including strategies, policies, procedures, and master plans. Lead recurring validation forums and governance teams; manage overarching validation activities and 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; assist with resolving technical issues and generating reporting documentation. Interface with system owners, IT and facilities engineering to ensure tests meet user and compliance requirements; support creation of requirements for new equipment or systems. Author, execute, and/or approve technical documents such as validation protocols, reports, user requirements, deviations, risk assessments, or product reports. Manage contracted validation service providers to ensure requirements are fulfilled through performance monitoring and agreements; evaluate vendor qualification packages and create supplemental protocols as necessary. Lead and mentor validation staff; support continuous improvement, monitoring, sustaining validation practices and records. Ensure validation status is updated for new systems and changes via science-based risk assessments and change management policies. Ensure data integrity requirements are incorporated in validation activities for facilities/utilities, equipment, automated systems and processes. Act as SME with validation software (e.g., Ellab ValSuite) for mapping studies. Maintain close contact with manufacturing, facilities, and laboratory departments to ensure effective communication on validation issues and validated state of equipment. Accountable for on-time delivery of validation deliverables. Lead development of testing strategies and rationale for equipment/systems; collaborate with stakeholders on quality events and investigations; ensure quality records are thorough and well-reasoned. Serve as a resource fluent in Global Validation Strategy, ensuring GMP compliance with internal procedures and international regulations. Develop compliant validation processes and procedures to satisfy current and new compliance requirements. Qualifications Required
BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience in GMP-regulated industry, or Master’s degree with 5+ years; or 10+ years of related industry experience in lieu of degree. Strong knowledge of risk-based approaches to commissioning, qualification, and validation in biotech manufacturing. Demonstrated leadership, critical thinking, and ability to influence across the organization to meet milestones. Knowledge of cGMPs for biotechnology; working understanding of ICH Q7, Q8, Q9, Q10 and other regulatory requirements. Ability to interpret regulatory rules and apply Quality-by-Design principles; proficiency in deviation investigations, root cause analysis, CAPA, and risk assessments; proficient in Microsoft Office. Excellent technical writing, and verbal and written communication; ability to work cross-functionally to achieve milestones. Experience interacting with regulatory agencies and providing technical deliverables as a subject matter expert; audit hosting/support. Preferred
Specialized knowledge in niche topics such as bar coding, cell culture, auditing techniques, QC methods, HEPA filtration, etc. Experience with CMO oversight and regulatory compliance considerations. ASQ certifications (e.g., CQE, CQA, CPQ). Experience with electronic document management systems. Working Environment
This position is based in Westborough, MA and requires on-site work. Frequent work in a cleanroom environment. Physical activities including long periods of sitting/standing, lifting up to 20 lbs as needed. Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off including Vacation, Sick time, plus holidays 401(k) match and company contribution Company paid life insurance Annual Corporate Bonus and Quarterly Incentives for eligible positions Long Term Incentive Plan for eligible positions EOE including Disability/Protected Veterans
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