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Role 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 subject safety, data integrity, and operational impact, and escalate 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
100% remote work allowed from anywhere in the U.S.
Qualifications
• Bachelor’s degree in Pharmacy, Regulatory Affairs, Clinical or related field
• 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
Requirements
• Full time
• $116,000.00-$196,000.00 per year
Company Description
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.
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