Astellas Pharma
Validation Manager
– Astellas Pharma Institute for Regenerative Medicine (AIRM), Westborough, MA
Join Astellas Pharma, a global biopharmaceutical company focused on developing innovative therapies that transform patient care. AIRM, headquartered in Massachusetts, is advancing stem cell and cell‑therapy medicines for a broad range of indications.
Purpose The Validation Manager leads 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’s cGMP Cell Therapy Manufacturing facility. The role provides capital project oversight, develops validation strategy, manages validation project teams, and ensures compliance with FDA, EMA, ICH, Japan guidance and Astellas policies.
Essential Job Responsibilities
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.
Qualifications Required
BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience within GMP‑regulated industry, or Masters degree with 5+ years of direct validation experience. In lieu of a Life Sciences, or equivalent degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
Experience as a people manager.
Strong knowledge of risk‑based approach to commissioning, qualification, and validation activities in a biotech manufacturing environment.
Demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones.
Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk‑based decisions, and exercise sound Quality‑by‑Design principles.
Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
Working fluency in the Microsoft Office productivity suite (including Excel to include basic formulas, and creation / formatting of charts and data tables, and PowerPoint).
Solid technical writing skills and ability to document work in a meticulous, accurate and timely manner. Solid written and oral communication skills and ability to work interdepartmentally independently in an effective manner to achieve validation milestones and deliverables.
Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
Preferred
Specialized knowledge of industry‑related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.
ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
Experience with an electronic document management system
Working Environment
This position is based in Westborough, MA and will require on‑site work.
This position will require working frequently in a cleanroom environment.
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20 lbs.
Salary Range: $107,100 – $168,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year‑end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company‑paid fleet vehicle for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
#J-18808-Ljbffr
– Astellas Pharma Institute for Regenerative Medicine (AIRM), Westborough, MA
Join Astellas Pharma, a global biopharmaceutical company focused on developing innovative therapies that transform patient care. AIRM, headquartered in Massachusetts, is advancing stem cell and cell‑therapy medicines for a broad range of indications.
Purpose The Validation Manager leads 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’s cGMP Cell Therapy Manufacturing facility. The role provides capital project oversight, develops validation strategy, manages validation project teams, and ensures compliance with FDA, EMA, ICH, Japan guidance and Astellas policies.
Essential Job Responsibilities
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.
Qualifications Required
BS/BA in Life Sciences, Engineering, or Chemistry with 8+ years of direct validation experience within GMP‑regulated industry, or Masters degree with 5+ years of direct validation experience. In lieu of a Life Sciences, or equivalent degree, consideration will be given to candidates with minimum of 10+ years of industry experience in biotechnological and/or pharmaceutical quality, manufacturing, or other industry requiring high technical aptitude and attention to detail.
Experience as a people manager.
Strong knowledge of risk‑based approach to commissioning, qualification, and validation activities in a biotech manufacturing environment.
Demonstrated leadership, critical thinking skills, and ability to influence across the organization to achieve milestones.
Demonstrated knowledge of cGMPs for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements.
Ability to interpret regulatory rules, guidance, and normative industry standards to make objective, risk‑based decisions, and exercise sound Quality‑by‑Design principles.
Fluency in Deviation investigation techniques, root cause analysis methods, CAPA effectiveness verification, and product impact assessments.
Working fluency in the Microsoft Office productivity suite (including Excel to include basic formulas, and creation / formatting of charts and data tables, and PowerPoint).
Solid technical writing skills and ability to document work in a meticulous, accurate and timely manner. Solid written and oral communication skills and ability to work interdepartmentally independently in an effective manner to achieve validation milestones and deliverables.
Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert, audit hosting / support, etc.
Preferred
Specialized knowledge of industry‑related niche topics: bar coding, cell culture, auditing techniques, QC methods, HEPA filtration science, etc.
Experience with Contract Manufacturing Organization (CMO) oversight and compliance considerations.
ASQ certifications (e.g., certified quality engineer, quality auditor, quality professional, etc.)
Experience with an electronic document management system
Working Environment
This position is based in Westborough, MA and will require on‑site work.
This position will require working frequently in a cleanroom environment.
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20 lbs.
Salary Range: $107,100 – $168,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year‑end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Company‑paid fleet vehicle for eligible positions
Referral bonus program
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
#J-18808-Ljbffr