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Job Description

About the role:

As the Site Quality Head you will lead the Takeda Brooklyn Park Quality organization. Design and implement the Quality organizational structure. Design & direct Quality’s talent development program in alignment with HR and site programs. Build and maintain a best in class Quality team focused on biologics manufacturing and testing excellence.

Create the Quality vision for Brooklyn Park to drive implementation of processes and systems that ensure continuous global GXP compliance. Set the Quality culture of Brooklyn Park through focus on people, science, and systems.

Own and drive budget and resource planning, tracking and accountability for the Quality organization, in close collaboration Global Manufacturing and Supply

Key member of the Brooklyn Park Leadership team. Establish and drive Quality goals, support site goals, in close collaboration with site leadership.

How you will contribute:

• Design and lead the implementation of quality systems and procedures at Brooklyn Park. Ensure alignment with Global Quality policies.

• Create site Quality initiatives that are aligned with Global Quality, Global Manufacturing and Brooklyn Park operational strategies as a Center of Excellence in Biologics Manufacturing.

• Lead all Quality functions at the site: QC analytical and microbiology laboratories, QA, Quality Systems, Quality Compliance, and Quality Services & Improvement.

• Provide strategic support, coaching, and leadership to site Quality team and cross-functional organization. Champion talent development and mentoring.

• Chair the Brooklyn Park material review board. Quality authority for Brooklyn Park batch quality decisions.

• Lead inspections of Brooklyn Park by Health authorities including FDA, EMA, and global HA’s. Ensure Brooklyn Park maintains inspection readiness.

Minimum Requirements/Qualifications:

• 10 years of progressive experience in Quality or related disciplines within a Pharmaceutical company.

• Experience with pharmaceutical cell culture and purification manufacturing.

• Demonstrated high degree of influence and collaboration at the site Leadership Team level.

• Strong leadership skills: ability to build and motivate teams, mentoring/re-directing as required, in order to deliver on ambitious site goals, and wider company goals.

• Experience in facility design, risk management, validation, analytics and microbiology, within a GXP environment.

• In depth knowledge of the global regulatory environment for manufacture of biologics.

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, 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/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.

• Regular on-site attendance is necessary to perform the essential functions of the job.

• Light work, lifting up to 10lbs; frequent standing/walking.

• Site-focused position. Occasional US and global travel, generally less than 10%

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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