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Job Description

Job Title: Senior Manager, Validation, Cell Therapy Quality

Location: Cambridge, MA

About the role:

The Senior Manager, Validation, Cell Therapy Quality will report to the Director Cell TherapyProduct Quality and promotes and oversees the quality assurance processes for the Facilities, Equipment, and Validation Lifecycle, including computerized systems, in the Cell Therapy Manufacturing Facility. This important role ensures that all activities strictly follow relevant procedures and regulatory requirements. Oversee QA activities related to the commissioning, qualification, automation, and validation processes for a GMP manufacturing facility. This role shall ensure providing expert guidance, reviewing, and approving all commissioning and qualification activities, and equipment and process validations. Additionally, the role includes assessing protocols and reports related to digital automation for data management and manufacturing processes. Implement site validation master plan, review SOPs and make recommendations. Identify compliance issues with equipment/software used at CTMF as the Subject Matter Expert (SME) in Computer System Validation requirements. Champion QA support for continuous improvement projects, including data integrity programs within the laboratory and manufacturing environment. This role shall guide the successful implementation of continuous improvement initiatives by leading as the QA representative. This includes coordinating efforts for CAPA-driven improvements, adopting new technologies, and advocating for practices. This role shall support the objective by enhancing the quality and effectiveness of processes for data integrity within the laboratory and manufacturing environment.

How you will contribute:

• Implement site validation master plan, review SOPs, and make recommendations.
• Operate at a high level of decision-making, involving strategic input and authority in establishing validation plans, validation strategies, specifications, and qualification protocols. You will provide expert guidance, makes critical approvals, and ensures compliance with regulatory requirements. As a Subject Matter Expert (SME), you will influence main decisions across several departments and works with Manufacturing Operations, vendors, and other sites/networks.
• Provide expert guidance, reviewing, and approving all commissioning and qualification activities, and equipment and process validations. Additionally, the role includes assessing protocols and reports related to digital automation for data management and manufacturing processes.
• Ensure compliance with data integrity requirements and implement measures to maintain data integrity throughout the validation lifecycle. Ensure software validation is performed adequately: reviewing, approving protocols, and participating in test script performance with IT.
• Provide professional expertise, guidance, and in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/ GAMP 5) as applicable to equipment/software at Takeda's Cell Therapy Manufacturing Facility (CTMF).
• Author local site-specific quality lifecycle management documents for facilities, equipment, and validation including protocols, reports, and records.
• Review internal and external validation protocols and technical reports for validation/qualification of facility, equipment, and systems.
• Approve preventive maintenance, calibration, and work orders in the electronic asset management system.
• Review and guide in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Perform change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, and computer system validation
• Collect and report Quality Metrics in the field of responsibilities.
• Interact with the quality team and your team

What you bring to Takeda:

• Bachelor's Degree in a scientific field Microbiology, Biology, Chemistry, Engineering, or a related field
• Minimum of 7 years of pharmaceutical GMP experience including at least 5 years in GMP developing equipment qualification, and computerized systems validation projects in a Quality Assurance or Technical Services capacity.
• Knowledge of global regulatory requirements for validation, including current GAMP, ASTM-E2500, ICH guidelines and USP, 21CFR210, 21CFR211, and 21CFR11.
• Cleanroom experience.
• Working experience in biologics, cell or gene therapy product testing, manufacturing, and development.
• Experience in regulatory agency inspection.

Abilities/Experience:

• In-depth knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond to latest quality situations.
• Proficient in DI principles, and applicable regulations for Cell Therapies.
• Proficient in the application of validation principles and analyzing data to identify issues and performance trends.
• Distinguish between criticalities of quality issues and identify issues or topics for management escalation. Issue promptly.
• Independently manage projects, carries out root-cause investigations, analyzes data, and makes recommendations to management.

ADDITIONAL INFORMATION

• You will support biopharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities and analytical laboratories (this list is not exhaustive).

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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