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Job Description

Job Title: Quality Assurance Value Stream Manager

Location: Lexington (USA)

About the role:

In this role, you will act as an experienced Quality Assurance professional who will lead the QA Operations function in supporting key programs at MA Bio Ops, including New Product Introduction and Technical Transfer projects, program risk assessments, and continuous improvement activities. You will represent QA Operations on project teams, providing direction and ensuring a compliant, Quality mindset.

As a partner for New Product Introduction and Technical Transfer activities, the position will work with project teams to ensure phase appropriate controls are implemented for the manufacturing, testing and disposition of clinical phase drug substance, following global standards.

Additionally, you will provide Quality support for regulatory filing activities, inspection preparedness, and incident escalation above site.

How you will contribute:

• Participate in new product, tech transfer, and project meetings, representing QA Operations for the site.


• Perform gap assessments, risk assessments, and site risk review activities.


• Provide QA Floor and QA Technical/Dispo teams with support by performing approval of Quality Systems such as deviations and change controls and calibration system records.


• Attend visual management boards as agreed on by QA team.


• Uphold data integrity and GxP standards across the Quality and Manufacturing organization.


• Close partnership with other groups responsible for Documentation, Validation, Technical Services, Investigations, Project Management, Reliability, Facilities & Maintenance, Scheduling, and Tech Transfer.


• Report on agreed upon metrics and attend Visual Tier boards as appropriate.


• Drive a continuous improvement mindset within the QA Operations team by purposeful critical assessment of QA processes and improvement identification, support CI activities within the larger Mass Bio Ops site.


• Demonstrate Shingo principles through respect for individuals and focus on process, and Gemba walks.

• Bachelor's degree in a related discipline such as science, engineering, or another technical field.


• 6+ years experience in a biotech or pharmaceutical GMP setting associated with quality operations or compliance.

• Comprehensive Healthcare: Medical, Dental, and Vision


• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan


• Health & Wellness programs including onsite flu shots and health screenings


• Generous time off for vacation and the option to purchase additional vacation days


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional training opportunities


• Tuition reimbursement

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.


• Need to remove all make-up, jewelry, contact lenses, nail polish and 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.

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 to 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.

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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

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time