Senior RBQM Leader: Risk‑Based Quality for Global Trials

Otsuka America Pharmaceutical Inc.; Hagåtña (GU); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director of Risk Based Quality Management to develop, implement, and optimize RBQM frameworks across the clinical trial portfolio.

This remote, full-time role partners with Clinical Management, Data Management, Biostatistics, QA, Safety, and vendors to embed a data-driven oversight model aligned with global regulatory expectations. You will lead RBQM strategy, risk assessment, operational analytics, and process improvements while ensuring

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Experience in risk-based quality management (RBQM) and centralized monitoring.
• Strong data analytics and regulatory knowledge for trial oversight.

Responsibilities

• Lead RBQM strategy, governance, and metrics across trials.
• Guide risk identification, evaluation, and escalation processes.
• Oversee centralized monitoring and data-driven decision making.
• Drive continuous RBQM process improvements and automation.
• Collaborate with CROs/vendors to ensure RBQM alignment and compliance.
• Support regulatory inspection readiness and CAPA activities.
• Oversee budget/financial aspects and vendor performance.
• Lead team onboarding, training, and performance reviews.

Skills

RBQM

Centralized Monitoring

Clinical Data Analytics

Leadership

Regulatory Knowledge

Education

Bachelor’s degree in life sciences or related field

Advanced degree preferred

Tools

RBQM tools

Clinical Systems

Data Visualization Platforms

Analytics Dashboards

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director of Risk Based Quality Management to develop, implement, and optimize RBQM frameworks across the clinical trial portfolio.

This remote, full-time role partners with Clinical Management, Data Management, Biostatistics, QA, Safety, and vendors to embed a data-driven oversight model aligned with global regulatory expectations. You will lead RBQM strategy, risk assessment, operational analytics, and process improvements while ensuring