Remote Associate Director, Risk-Based Quality Management

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match and retirement plan

Paid holidays and paid time off

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking a seasoned Associate Director, Risk Based Quality Management to lead RBQM strategy across the clinical trial portfolio.

You will collaborate with Clinical Management, Data Management, Biostatistics, and external partners to embed risk-based oversight aligned with global regulatory expectations. The role emphasizes data-driven decision making, performance monitoring, and continuous RBQM improvements across trial design, conduct, and closeout.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Minimum 8 years in pharma/biotech, RBQM or related trial operations.
• Strong experience in risk-based quality management and centralized monitoring.

Responsibilities

• Develop, enhance, and govern RBQM operating model and metrics.
• Lead risk assessment, mitigation, and study-level oversight plans.
• Oversee centralized monitoring strategies and data-driven decision making.
• Drive RBQM process improvements, digital tools, and automation integration.
• Ensure CROs and vendors align with RBQM requirements and timelines.

Skills

RBQM experience

Cross-functional leadership

Data analytics

Risk assessment

Regulatory knowledge

Project management

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. is seeking a seasoned Associate Director, Risk Based Quality Management to lead RBQM strategy across the clinical trial portfolio.

You will collaborate with Clinical Management, Data Management, Biostatistics, and external partners to embed risk-based oversight aligned with global regulatory expectations. The role emphasizes data-driven decision making, performance monitoring, and continuous RBQM improvements across trial design, conduct, and closeout.