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Job Description

Job Title: Principal Manager, Cell Therapy Quality Compliance

Location: Cambridge, MA

About the role:

You will report to the Director, Cell Therapy, Quality Compliance and provide leadership for the daily execution and improvement of a variety of processes and activities that ensure the continued compliance of the Cell Therapy/Cell Therapy Quality organization. You will support the rollout and implementation of new processes, procedures, and improvements associated with internal cGMP manufacturing and testing of clinical-phase cell therapy programs. Independently lead the development of cGMP quality compliance processes and continuous improvement efforts which support clinical-phase cell therapies and continued process excellence. You will be main resource for us as a subject-matter-expert and partners with team members and your team in advancing quality and compliance.

How you will contribute:

• Lead across the site/organization for operation within the global Document & Learning Management Systems, including managing workflows, assigning curricula, capturing metadata, and related activities. Ensure curricula are structured per defined training plans in the Learning Management System.
• Facilitate developing curricula for on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approval.
• Work with organization management to ensure learning plans and training matrices are established and maintained across CTQ. Provide leadership support to CT partners to ensure same.
• Primary contact and SME for risk management activities, and ownership of risk register documentation for CT cGMP operations. Partner with team members and partners for training and guidance on risk management activities. Work with risk owners to develop risk mitigation plans.
• Facilitate risk assessment sessions and lead team members to complete risk assessments relating to GXP processes
• Establish and maintain productive relationships with Takeda Global Quality and R&D Quality Compliance & Systems personnel to represent CT/CTQ in Quality e-system improvement projects, system configuration changes and associated activities applicable to frequently used modules (e.g., documentation, learning, change control, deviation, CAPA).
• Independently analyze metrics/performance reports associated with the performance of cGMP operations and the Quality Management System. Organize and analyze data, identify trends, and offer solutions; prepare Quality Council slides and support presentation of information in Quality Councils.
• Serve as a necessary resource for other CTQ personnel to provide guidance concerning quality management systems and compliance.
• Interact with quality team members and team members to support site goals and projects; serve as management back-up/representative where needed.
• Independently identify quality and compliance gaps, communicate to management, and propose solutions. Implement endorsed solutions.
• Champion improvement and wants to lead efficiency by implementing novel ideas and leading optimization projects.
• Maintain knowledge of global regulatory requirements for cell therapy products and ensure compliance.

What you bring to Takeda:

• Bachelor's Degree in Biology, Microbiology, Chemistry or related field. Master' Degree preferred.
• 5+ years of experience
• Experience in cell or gene therapy product testing, manufacturing and development

Technical/Functional (Line) Expertise

• Demonstrated knowledge of global regulations and guidance governing cell therapies. Communicate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations.
• In-depth knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions and respond to new quality situations.
• Experienced with risk management strategies and general project management. Experience implementing continuous improvement programs
• Proficient in analyzing data to identify performance trends
• Distinguish between criticalities of quality issues and identify issues or topics for management escalation independently. Promote issues promptly.
• Independently manage projects, carries out root-cause investigations, analyzes data and makes recommendations to management.

Additional Information

• This role supports 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. 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.

For Location:

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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Job Exempt