Astellas Pharma · 3 days ago
Validation Manager
Westborough, MA
Full-time
Onsite
Mid, Senior Level
$107K/yr - $168K/yr
5+ years expAstellas Pharma Inc. is a global pharmaceutical company dedicated to developing innovative therapies for patients. The Validation Manager will lead a team responsible for overseeing validation programs and ensuring compliance with global regulatory standards in the cGMP Cell Therapy Manufacturing facility.
BiotechnologyHealth CareMedical
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
Qualification
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
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 fleet vehicle for eligible positions
Referral bonus program
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2025-12-18
Company data provided by crunchbase