Clinical Program Quality Manager

Takeda•Boston, MA

10d•$116,000 - $196,000•Remote

About The Position

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.
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.

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
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