Clinical Program Quality Manager

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Job Description

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Takeda Development Center Americas, Inc. for the following job opportunity:

JOB LOCATION: Cambridge, MA

POSITION: Clinical Program Quality Manager

POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Clinical Program Quality Manager with the following duties: Support GCP compliance activities for oncology clinical trials through the development and implementation of program-specific, risk-based audit and compliance strategies; conduct audits of investigator sites, clinical documentation, vendors, and internal systems to ensure adherence to GCP, regulatory requirements, and internal policies; assess audit findings and compliance risks, with a focus on the subject safety, data integrity, and operational impact, and escalates significant issues to management; manage Takeda and CRO-related quality investigations, ensuring they are comprehensive, timely, and compliant with SOPs and regulatory expectations; perform Principal Investigator (PI) checks prior to study initiation by reviewing audit and quality investigation reports to confirm investigator readiness and compliance history; provide support during regulatory inspections, including preparation of responses and coordination of follow-up actions; collaborates with cross-functional teams and quality functions to identify and mitigate systemic GCP compliance issues across oncology programs; analyze and report compliance metrics to development teams and leadership, ensuring accurate documentation and timely communication; leverage prior experience in managing QMS documentation, governance materials, and operational oversight to support continuous improvement of quality systems and processes; contribute to the development of tools, templates, and guidance to enhance inspection readiness and quality oversight across clinical programs; analyze, report, and present metrics for assigned programs to development teams and CPMQ management; recommend any required actions and monitor implementation; 100% remote work allowed from anywhere in the U.S.

REQUIREMENTS: Bachelor’s degree in Pharmacy, Regulatory Affairs, Clinical or related field plus 5 years of related experience. Prior experience must include: Implement knowledge of the applicable GCP and GVP regulations and guidance and ICH Guidelines to support the study team; Identify and investigate the quality issues related to the functional processes; Analyze and assess the risk and impact of the quality events and develop appropriate corrective and preventive actions to improve the processes; Manage and track team projects, their timelines, and deliverables to ensure their completion in a timely manner.

Full time. $116,000.00-$196,000.00 per year

Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0169427. EOE

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210.

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