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Job Description

About the role

The Associate Director of Quality Control will lead the establishment of a state-of-the-art quality control laboratory. Responsibilities include overseeing its design, construction, qualification, and regulatory approval. Collaborate with global teams to align with Takeda’s laboratory-of-the-future strategy, focusing on automation and paperless systems. Hire and train the Quality Control team, eventually overseeing lab operations to support a 24/7 pharmaceutical manufacturing site.

How you will contribute

·Lead the planning and execution of a new Quality Control Laboratory startup, ensuring full compliance with regulatory standards.

·Design and implement efficient lab processes and workflows to optimize operational performance and throughput.

·Collaborate cross-functionally with IT, R&D, and Manufacturing to ensure seamless system integration.

·Oversee the selection, validation, and implementation of laboratory automation technologies and LIMS platforms.

·Develop and enforce SOPs that uphold the highest standards of safety and quality.

·Manage resources, timelines, and deliverables to ensure a successful and timely lab launch.

·Recruit, train, and lead a high-performing laboratory team, fostering a culture of excellence and accountability.

·Stay current with industry best practices, emerging technologies, and regulatory developments to drive innovation.

·Develop and manage departmental budgets, ensuring alignment with organizational goals and fiscal responsibility.

·Promote team development, engagement, and retention through effective leadership and mentorship.

·Communicate and present effectively to senior leadership and key stakeholders.

·Supervise and support technical teams in a regulated environment, ensuring operational excellence.

·Lead and support regulatory audits and submissions with confidence and precision.

·Maintain clear and consistent communication with the Site Quality Head regarding quality and safety matters.

What you bring to Takeda

·Bachelor’s degree in science, engineering, or a related technical field.

·Minimum of 8 years of industry experience, including at least 3 years in a managerial or leadership role.

·Demonstrated expertise in Quality Assurance, Quality Control, and laboratory startup operations.

·Strong working knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), and EU regulatory standards.

·Proven ability to lead teams and thrive in dynamic, fast-paced environments.

·Proficient in assessing quality risks and authorized to approve or reject laboratory results.

·Active participation in global forums to stay informed on industry innovations and best practices.

·Deep understanding of Quality Control and Sterility Assurance, including experience with technical upgrades and system improvements.

·Skilled in applying risk management principles to daily operations and decision-making.

·Ability to safely manage hazardous and biological materials in compliance with safety protocols.

About our Round Lake Facility:

Takeda's manufacturing facility in Round Lake, Illinois, is an integral part of Takeda’s Plasma Network. Close in proximity to both Chicago and Milwaukee, the state-of-the-art facility specializes in producing Flexbumin through the GALAXY manufacturing process. Flexbumin is albumin, contained in a flexible pouch, for patients who experience a loss of plasma volume from situations such as trauma, surgery, blood loss and burns. Round Lake supplies its product to patients all over the world, with key markets in the U.S., China, and India.

Join us to make a difference.

What Takeda can offer you:

• 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

• Flexible Work Paths

• Tuition reimbursement

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. 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.

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 posting excludes Colorado applicants.

Empowering our people to shine:

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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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.

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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.

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