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

Purpose:

The Validation Lead, Quality Assurance, is 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 capital project oversight for validation, determining and leading validation strategy, and managing validation project teams. 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 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 Master’s 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.

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 20lbs.

Benefits:

Medical, Dental and Vision Insurance

Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

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

Referral bonus program

Category BioPharma QA

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans