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Job Description

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.

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 startup planning and execution of the Quality Control Lab, ensuring regulatory compliance.

·Design efficient lab processes and workflows.

·Collaborate across IT, R&D, and manufacturing to integrate systems.

·Oversee selection and validation of lab automation and LIMS.

·Develop SOPs to uphold safety and quality standards.

·Manage resources and timelines for successful lab launch.

·Recruit and train a high-performing lab team.

·Stay updated on industry best practices and technologies.

·Develop and manage department budgets and adherence.

·Cultivate team development and retention.

·Present effectively to leadership and stakeholders.

·Supervise and manage a team.

·Lead and support regulatory audits and submissions.

·Maintain effective communication with the Site Quality Head for quality and safety issues.

Minimum Requirements/Qualifications:

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

·8+ years of industry experience, including 3+ years in a managerial role.

·Proven experience in Quality Assurance, Quality Control, and lab startups.

·Strong knowledge of FDA, cGMP, and EU regulations.

·Proven ability to manage teams and work in dynamic environments.

·Competence in assessing quality risks, with authority to approve or reject results.

·Participation in global forums to keep updated on best practices and industry innovations.

·In-depth understanding of QC and Sterility Assurance, including technical upgrades.

·Apply effective risk management principles in daily operations.

·Ability to manage hazardous and biological materials safely.

Important Considerations

Physical Demands

• Ability to lift up to 10 lbs; sedentary work and facility observation required.
• Compliance with cleanroom gowning standards.

Working Environment and Schedule

• Indoor working conditions anticipated.
• Flexible to work various shifts and extended hours for continuous manufacturing support, including weekends and holidays.

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 paid time off for vacation, sick leave, and volunteering
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Professional development and training opportunities
• Tuition reimbursement

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.

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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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Job Exempt