Associate Director, Head of IMP Quality

Job Description About the Role

Takeda is seeking an experienced Associate Director, Head of IMP Quality to lead quality operations for investigational medicinal products (IMPs) from clinical development through to commercialization. This role provides strategic, industry‑leading oversight of Takeda’s quality processes, ensuring compliance with global regulations, cGMP standards, and corporate policies.

As the head of a highly skilled team, you will define quality standards, oversee audits, manage deviations, and lead process improvement initiatives. You will play a key role in supporting Takeda’s mission to deliver high‑quality, safe, and effective therapies to patients worldwide.

• Provide strategic leadership and oversight of a team of QA managers, ensuring continuous professional development and operational excellence.
• Review, approve, and release clinical trial materials, including batch records, analytical protocols, and packaging labels.
• Ensure compliance of Takeda’s development products with regulatory requirements, cGMP, and Takeda Quality standards.
• Ensure adequate investigations of quality issues and implement corrective and preventive actions to prevent recurrence.
• Support regulatory submissions, pre‑approval inspection readiness, and external audits.
• Drive continual improvement initiatives and process optimizations to enhance operational efficiency.
• Build strong relationships across internal stakeholders, partners, and external suppliers to achieve agility for pharmaceutical development and high‑quality outcomes.

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Engineering, or related field (advanced degree preferred).
• Minimum of 7 years of experience in pharmaceutical manufacturing, packaging, laboratory, or QA/QC/compliance environment.
• Proven leadership experience with the ability to motivate, mentor, and develop high‑performing teams.
• In‑depth knowledge of international regulatory requirements and cGMP practices.
• Strong analytical, problem‑solving, and decision‑making skills in complex, global environments.
• Excellent communication and collaboration skills; ability to influence cross‑functionally at all levels.
• Willingness to travel up to 10%, including domestic and international trips.
• Quality auditor certification preferred.

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.

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, or any other characteristic protected by law.

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.

Lexington, MA

U.S. Base Salary Range: $ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or…