Takeda · 2 weeks ago
Clinical Program Quality Manager
United States
Full-time
Remote
Senior Level
$116K/yr - $196K/yr
5+ years expTakeda Development Center Americas, Inc. is seeking a Clinical Program Quality Manager to support GCP compliance activities for oncology clinical trials. The role involves conducting audits, managing quality investigations, and collaborating with cross-functional teams to ensure compliance and improve quality systems.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
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
Collaborate 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
Qualification
Required
Bachelor's degree in Pharmacy, Regulatory Affairs, Clinical or related field plus 5 years of related experience
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
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
Pharmaceutical Technology
2026-01-11
2026-01-09
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