Associate Director, Head of IMP Quality

Job Description

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.

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 strive to be more transparent with our pay practices.

Location:

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 qualifications, years of relevant experience, specific skills, level of education, certifications, and location.

U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, well‑being benefits, and up to 80 hours of sick time per calendar year. New hires are eligible to accrue up to 120 hours of paid vacation.

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.

Lexington, MA

Employee

Regular

Full time

Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer that violates this law shall be subject to criminal penalties and civil liability.