Associate Director, Head of IMP Quality at Takeda Pharmaceuticals

Lexington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

18 Sep, 26

Salary

242550.0

Posted On

20 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, cGMP, Regulatory Compliance, Team Leadership, Audit Management, Deviation Management, Process Improvement, Clinical Trial Materials Release, CAPA, Strategic Leadership, Analytical Problem Solving, Cross-functional Collaboration

Industry

Pharmaceutical Manufacturing

Description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. 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. How You Will Contribute 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. Skills and Qualifications 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. Empowering our people to shine: 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. 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. For Location: Lexington, MA U.S. Base Salary Range: $154,400.00 - $242,550.00 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 local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 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, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 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. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.

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Responsibilities

Lead quality operations for investigational medicinal products from clinical development through commercialization. Provide strategic oversight of QA managers to ensure compliance with global regulations and cGMP standards.