By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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, a