Associate Director, Head of IMP Quality

Takeda • Lexington, MA

17h

About The Position

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.

Requirements

• 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.

Nice To Haves

• Quality auditor certification preferred.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees