Clinical Program Quality Manager

Role Summary

The Clinical Program Quality Manager is responsible for leading GCP compliance activities for oncology clinical trials, developing program-specific audit and compliance strategies, and coordinating quality initiatives across Takeda’s oncology programs. The role involves conducting audits of investigator sites, documentation, vendors, and internal systems to ensure adherence to GCP, regulatory requirements, and internal policies; managing quality investigations; supporting regulatory inspections; and reporting on compliance metrics. This position is 100% remote within the U.S. and located in Cambridge, MA.

Responsibilities

• Support GCP compliance activities for oncology clinical trials through 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, focusing on subject safety, data integrity, and operational impact; 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 experience in managing QMS documentation, governance materials, and operational oversight to support continuous improvement of quality systems and processes.
• Contribute to 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 actions and monitor implementation.
• 100% remote work allowed from anywhere in the U.S.

Qualifications

• Required: Bachelor‚Äôs degree in Pharmacy, Regulatory Affairs, Clinical or related field; 5 years of related experience.
• Required: Knowledge of applicable GCP and GVP regulations and guidance and ICH Guidelines to support the study team.
• Required: Ability to identify and investigate quality issues related to functional processes; analyze risk and impact of quality events; develop corrective and preventive actions.
• Required: Experience managing and tracking team projects, timelines, and deliverables to ensure timely completion.

Education

• Bachelor‚Äôs degree in Pharmacy, Regulatory Affairs, Clinical or related field.