Manager, Cell Therapy Quality Compliance

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Job Description

Job Title: Manager, Cell Therapy Quality Compliance

Location: Cambridge, MA

About the role:

The Manager, Cell Therapy Quality Compliance & Systems will focus on Compliance Systems requirements specific to internal cGMP manufacturing and testing of clinical-phase cell therapy programs. You will establish and maintain Quality Compliance governance and processes, and improving performance associated with Takeda’s internal cell therapies manufacturing facility. You will manage adherence to Quality Management System (QMS) requirements within the facility and directly manages the development of cGMP quality procedures for clinical-phase cell therapies., you will report to the Director, Cell Therapy Compliance.

How you will contribute:

• Manage review, gap assessment and implementation of global and local GMP documents (e.g., Standards, SOPs, Job Aids) to ensure seamless integration of the QMS.

• Lead evaluation of metrics and performance reporting as part of Quality Councils. Organize and analyze data and identify trends to offer solutions.

• Accountable for the effectiveness of local training program. Develop training material for local processes.

• Oversee facility records management and ensure compliance with company and regulatory requirements.

• Comply with data integrity requirements and ensure local procedures are aligned with global requirements.

• Be a key contact and local subject-matter expert for QMS systems (e.g. change control, deviation, CAPA). Investigate system failures and ensures successful resolution. Conduct training for new users. Apply systems knowledge to offer practical solutions and minimize compliance risk.

• Help with the preparation and review of incidents as part of the Quality Incident Management process.

• Manage internal quality improvement projects; evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs.

• Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance.

Minimum Requirements/Qualifications:

• Bachelor’s Degree in Chemistry, Biology, Engineering, or related field. Master’s preferred.

• 7+ years of experience in the biotech industry.

• 5+ years of Quality/cGMP Compliance experience

• Specific experience in the following:

  • Cell and/or gene therapy product manufacturing or testing

  • Investigational medicinal products

• Experience working in an internal biopharmaceutical development environment

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.

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.

LocationsBoston, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes