Head of Quality Control

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About the role:

As the Director of Quality Control, you will lead the full scope of Quality Control operations, overseeing analytical chemistry, microbiology, and laboratory excellence to ensure rigorous, reliable, and compliant testing across the organization. You will establish and elevate QC standards, drive alignment with industry and regulatory expectations, and partner closely with Manufacturing and cross‑functional Quality leaders to advance Safety, Quality, Compliance, financial performance, employee development, customer satisfaction, and key digital and continuous improvement initiatives tied to the site’s strategic plan.

You will be a visible champion of Takeda’s Quality Culture—Keeping it Simple, Taking Pride in Doing it Right, Ensuring a Speak Up Culture, and Owning and Demonstrating Commitment to Quality—while shaping a high‑performing team and a world‑class laboratory environment. You will report into the Site Quality Head.

• Responsible for the QC Laboratory functions, both Analytical Chemistry and Microbiology functions
• Responsible for managing, developing, and implementing compliant processes to ensure highest level of product quality
• Manage 24/7 QC laboratory team who is responsible for testing raw materials, intermediates, and finish drug products
• Ensure compliance with internal standards
• Ensure compliance with industry standards and regulations, staying up to date with any changes or updates
• Act as advisor to subordinates to meet schedules and/or resolve technical problems
• Identify and manage continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements
• Develop and maintain site contamination control program, with focus on sterility assurance
• Manage overall coaching, training, development and succession plans for the team
• Identify and implement digital innovation for QC laboratory

• BS in Science, Engineering, or a related field plus 10+ years of experience, 7 of which should be in a management role
• Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices
• Experience in interfacing and/or leading regulatory audits
• Demonstrated success in managing a large team
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• No make‑up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment, which in some areas is cold and wet, and require 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

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.

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.

USA - MA - Lexington - BIO OPS

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