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Job Description
About the role:
As the Cell Therapy QA Manager, you will lead and execute QA operational activities at Takeda’s internal GMP cell therapies manufacturing facility, ensuring compliance with regulations and Takeda procedures for clinical-phase cell therapy manufacturing and testing. Your role will involve direct management of the development, implementation, and maintenance of cGMP quality operational processes, with a specific focus on GMP QA support for manufacturing operations, and you will report to the Director, Cell Therapy Product Quality.
How you will contribute:
Employ GMP QA expertise to ensure product quality in the development, manufacturing, testing, and disposition of clinical-phase cell therapies.
Serve as the GMP QA subject matter expert for resolving deviations, investigations, and CAPAs compliantly.
Interact with quality team members and internal stakeholders to support site goals, projects, and issue resolution.
Manage internal quality improvement initiatives by evaluating processes, suggesting, designing, and implementing improvements, and revising relevant SOPs.
Maintain knowledge of global regulatory requirements for cell therapy products to ensure compliance.
Issue, review, and approve GMP documentation needed for internal manufacturing operations.
Review batch record documentation for compliance and accuracy, and make final disposition decisions for cell therapy investigational material.
Engage in daily onsite quality oversight, collaborating across functions to troubleshoot problems, interpret data, and apply a risk-based approach.
Represent QA in site operations, from thawing starting material to drug product filling and labeling.
Distinguish between criticalities of quality issues and identify issues or topics for management escalation independently. Explain issues and provide guidance to stakeholders.
What you bring to Takeda:
Bachelor’s Degree in Biology, Microbiology, Chemistry or related field.
4+ years of experience in cGMP Quality Assurance.
Experience working in a biopharmaceutical development/production environment. Working knowledge of cell therapy product testing, manufacturing or development is a plus.
Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies in field of responsibility.
Knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions and respond to new quality situations in field of responsibility.
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.
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).
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.
For Location:
Boston, MA
U.S. Base Salary Range:
96,600.00 - 151,800.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes