Director – Head of Quality Control Covington

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Job Description

About the role:

Are you seeking a patient-focused, innovation-driven company that will inspire and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Head of Quality Control at our Covington manufacturing site in Georgia.

Takeda is a global pharmaceutical leader. We have an unwavering dedication to putting people first, and we live our values of Takeda-ism—Integrity, Fairness, Honesty, and Perseverance. We are united by our over 240 legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine, and we need bright, forward-thinking, ambitious, and energetic people to support us on our journey.

Global Manufacturing & Supply and Global Quality (GMSGQ) is the backbone of Takeda. We strive to ensure that our medicines are available wherever our patients are. Takeda’s state-of-the-art manufacturing facility in Covington is one of the largest biotech production sites in the world. It has a key strategic role in our global manufacturing network, supplying quality therapies to our patients. Fresh air and stunning countryside on the fringe of Atlanta's cosmopolitan, multicultural city make Covington the ideal place to live and work.

This position is a member of the Site’s Leadership team, reports to the Site Quality Head, and oversees and manages all aspects of quality control within the organization, including, but not limited to, analytical chemistry, microbiology, and laboratory excellence.

This includes developing and implementing quality control standards and ensuring compliance with industry standards and regulations while partnering with the Manufacturing and other Quality leaders to drive improvements in Safety, Quality, Compliance, financial performance, employee development, customer satisfaction, and digital and continuous improvement initiatives consistent with the plant strategic plan. The incumbent will uphold Takeda’s Quality Culture elements of Keeping it Simple, Taking Pride in Doing it Right, ensuring a Speak-up Culture, and Owning and Demonstrating Commitment to Quality.

How you will contribute:

• Responsible for the QC Laboratory functions, both Analytical Chemistry and Microbiology.
• Responsible for managing, developing, and implementing compliant processes to ensure the highest level of product quality.
• Manages a 24/7 QC laboratory team responsible for testing raw materials, intermediates, and finished drug products.
• Ensures compliance with internal standards.
• Ensure compliance with industry standards and regulations, staying current with any changes or updates.
• Act as subordinates' advisor to meet schedules and/or resolve technical problems.
• Periodically reviews the suitability and effectiveness of the quality control system with senior management.
• Identifies and manages continuous improvement projects that may span multiple sections or departments to achieve quality, reliability, and cost improvements.
• Develops budget and ensures adherence to the budget.
• Manages overall coaching, training, development, and succession plans for the team.
• Develop and maintain a site contamination control program with a focus on sterility assurance.
• Responsible for identifying and implementing digital innovation for the QC laboratory.

What you bring to Takeda:

• Typically requires a bachelor's degree, preferably in science, engineering, or other related technical field. 10+ years of related experience with 7+ in a management role.
• Experience in running a large-scale, multi-function laboratory is strongly preferred.
• In-depth knowledge of industry standards and regulations related to quality control.
• Knowledge of FDA, EMA, CFDA, PDA Regulations, Good Data and Documentation Practices (GDDP), and application of current Good Manufacturing Practices (cGMP).
• Manages regulatory inspections and other pre-inspection readiness audits.
• Interacts with local and global regulators and is the key contact for regulatory inspections involving the laboratory.
• Experience with endotoxin and sterility testing is preferred.
• Strong analytical and problem-solving skills.
• Ability to work with multifunctional, global teams in a fast-paced setting.
• Strong leadership skills and demonstrated success in managing a large team.
• Prior experience in interfacing and/or leading regulatory audits.
• Ability to manage department budgets and staffing.
• Result-driven with ideas to drive continuous improvement and process simplification with breakthrough solutions, including digital.
• Knowledge of data analytics and Lean / Six Sigma concepts preferred.
• Understanding of new innovative laboratory concepts.
• Must be able to manage ambiguity and make decisions under stressful conditions.
• Challenges the status quo to drive continuous improvement and enhancements to operations in the Quality Control Department.

Important Considerations:

• Must be able to work in controlled environments requiring special gowning, follow gowning requirements, and wear protective clothing over your head, face, hands, feet, and body.
• Make-up, jewelry, contact lenses, nail polish, or artificial fingernails may not be worn in the manufacturing environment, which is cold and wet in some areas and requires personal protective equipment (PPE).
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• Must be able to work multiple shifts, including weekends.
• 10% Travel

More about us:

At Takeda, we are transforming patient care by developing 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.

#GMSGQ

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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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