Senior RBQM Data Enablement & Analytics Lead

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

Job summary

Takeda in Massachusetts (virtual) is seeking an experienced RBQM lead to configure and optimize the Centralized Monitoring platform, translate risk assessments into system specs, and promote best practices across study teams.

You will manage RBQM data flows, oversee platform operations, develop training, and collaborate with stakeholders including GDO, IT and CRO partners to support releases.

Qualifications

• 8+ years in pharma or CRO industry
• 3+ years Risk Based Quality Management
• 2+ years managerial experience
• Strong regulatory knowledge: 21 CFR Part 11, ICH E6, ICH E8
• Experience with sponsor audits and inspections
• Knowledge of RBQM IT or data analytic systems
• Data analysis and pattern recognition
• Cross-functional leadership and collaboration
• Influence without authority
• Strategic thinker with change management
• Attention to detail and problem-solving

Responsibilities

• Configure Centralized Monitoring platform and RBQM components.
• Translate risk assessments into system specs and configure RBQM.
• Lead study teams to follow RBQM best practices.
• Manage RBQM data flows across study, program, enterprise systems.
• Develop training materials and deliver training on RBQM.
• Oversee platform operations, user access and governance.
• Drive continuous enhancement of RBQM processes and tools.
• Coordinate with vendors and operations for releases.
• Act as SME for RBQM technology and data flows.

Skills

RBQM

Risk Based Quality Management

Cross-functional leadership

Data analytics

Regulatory knowledge

Process improvement

Change management

Communication

Ambiguity tolerance

Tools

RBQM IT systems

Data analytic systems

Job description

Takeda in Massachusetts (virtual) is seeking an experienced RBQM lead to configure and optimize the Centralized Monitoring platform, translate risk assessments into system specs, and promote best practices across study teams.

You will manage RBQM data flows, oversee platform operations, develop training, and collaborate with stakeholders including GDO, IT and CRO partners to support releases.