Remote RBQM Associate Director – Quality Risk

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

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Risk Based Quality Management to shape RBQM strategy across the clinical portfolio.

This remote, full-time role partners with management, data science, and QA to embed a data-driven risk oversight model aligned with global regulatory expectations. The position emphasizes proactive risk detection, operational oversight, and continuous process improvement, guiding CROs and vendors with a focus on inspection readiness and quality

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Strong experience in risk-based quality management and centralized monitoring.
• Familiarity with ICH guidelines and global regulatory expectations.

Responsibilities

• Lead the RBQM strategy, governance, and operating model across the trial portfolio.
• Oversee risk identification, evaluation, and escalation of deviations; manage Quality Tolerance Limits.
• Partner with cross-functional teams to ensure data-driven decision-making and centralized monitoring.

Skills

RBQM

Risk management

Data analytics

Cross-functional leadership

Regulatory knowledge

Education

Bachelor in life sciences

Advanced degree preferred

Tools

RBQM tools

Clinical data analytics platforms

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Risk Based Quality Management to shape RBQM strategy across the clinical portfolio.

This remote, full-time role partners with management, data science, and QA to embed a data-driven risk oversight model aligned with global regulatory expectations. The position emphasizes proactive risk detection, operational oversight, and continuous process improvement, guiding CROs and vendors with a focus on inspection readiness and quality