Director, Remote RBQM Data Enablement & Analytics

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Job summary

Takeda Pharmaceutical Co. in Massachusetts (Virtual) seeks an experienced RBQM Lead to configure and optimize the Centralized Monitoring platform, translate risk assessments into system specs, and champion RBQM best practices across study teams.

You will manage RBQM data flows, lead cross-functional meetings, and partner with operations, IT, and vendors to drive continuous improvement. Strong communication, leadership, and a strategic mindset are essential.

Qualifications

• Minimum of 8 years in the pharmaceutical or CRO industry.
• Minimum of 3 years in Risk Based Quality Management.
• Minimum of 2 years managerial and supervisory experience.
• Robust understanding of the drug development process and clinical trial execution.
• Knowledge of regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP).
• Experience with RBQM IT systems or other data analytic systems.
• Demonstrated ability to analyze data, identify patterns and make improvements.
• Demonstrated ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risks.
• Translate Study Risk Assessments into RBQM specifications and configure RBQM technology accordingly.
• Lead study teams to understand and follow RBQM best practices to maximize benefit.
• Manage and optimize RBQM dataflows across study, program, and enterprise systems.
• Develop training materials and deliver RBQM training as needed.

Skills

RBQM expertise

Leadership

Risk management

Data analysis

Cross-functional collaboration

Regulatory standards knowledge

Education

Pharma/CRO experience

Tools

RBQM IT systems

Job description

Takeda Pharmaceutical Co. in Massachusetts (Virtual) seeks an experienced RBQM Lead to configure and optimize the Centralized Monitoring platform, translate risk assessments into system specs, and champion RBQM best practices across study teams.

You will manage RBQM data flows, lead cross-functional meetings, and partner with operations, IT, and vendors to drive continuous improvement. Strong communication, leadership, and a strategic mindset are essential.