BioSpace
Job Description
Takeda Development Center Americas, Inc. is seeking a
Clinical Program Quality Manager
located in Cambridge, MA. Salary: $116,000.00-$196,000.00 per year. 100% remote work allowed from anywhere in the U.S. Full time.
Key responsibilities include:
Support GCP compliance activities for oncology clinical trials through 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, escalating 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.
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.
Requirements
Bachelor’s degree in Pharmacy, Regulatory Affairs, Clinical or related field plus 5 years of related experience.
Implement knowledge of applicable GCP and GVP regulations and guidance and ICH Guidelines to support the study team.
Identify and investigate quality issues related to functional processes.
Analyze and assess the risk and impact of quality events and develop appropriate corrective and preventive actions to improve processes.
Manage and track team projects, timelines, and deliverables to ensure completion in a timely manner.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0169427. EOE
#J-18808-Ljbffr
Clinical Program Quality Manager
located in Cambridge, MA. Salary: $116,000.00-$196,000.00 per year. 100% remote work allowed from anywhere in the U.S. Full time.
Key responsibilities include:
Support GCP compliance activities for oncology clinical trials through 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, escalating 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.
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.
Requirements
Bachelor’s degree in Pharmacy, Regulatory Affairs, Clinical or related field plus 5 years of related experience.
Implement knowledge of applicable GCP and GVP regulations and guidance and ICH Guidelines to support the study team.
Identify and investigate quality issues related to functional processes.
Analyze and assess the risk and impact of quality events and develop appropriate corrective and preventive actions to improve processes.
Manage and track team projects, timelines, and deliverables to ensure completion in a timely manner.
Qualified applicants can apply at https://jobs.takeda.com. Please reference job #R0169427. EOE
#J-18808-Ljbffr