Job Description
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. 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. Apply tot his job