Takeda · 11 hours ago
Associate Director, Head of IMP Quality
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
7+ years expTakeda 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 oversight of Takeda’s quality processes, ensuring compliance with global regulations and corporate policies.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Quality auditor certification preferred
Benefits
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-22
2026-01-19
2026-01-14
Company data provided by crunchbase