RBQM Strategy Lead - Risk-Based Quality Management

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

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Prescription drugs

Life Insurance

AD&D Insurance

Short-term Disability

Long-term Disability

Tuition Reimbursement

Student Loan Assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Risk Based Quality Management to lead RBQM strategy and governance across our clinical trial portfolio.

You will partner with Clinical Management, Data Management, Biostatistics, QA, Safety, and vendors to embed a data-driven oversight model aligned with global regulations. You will guide risk assessment, mitigation, and analytics, ensuring inspection readiness, continuous improvement, and regulatory compliance across programs

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 RBQM, risk management, and data analytics experience.
• Global regulatory knowledge including ICH/GCP expectations.

Responsibilities

• Develop RBQM strategy, governance, processes, and metrics.
• Lead risk identification, evaluation and monitoring across studies.
• Oversee centralized monitoring and data-driven decision making.
• Drive continuous RBQM process improvements and tools adoption.
• Collaborate with CROs, vendors, and internal teams for compliance.

Skills

RBQM

Risk management

Regulatory knowledge

Leadership

Data analytics

Cross-functional

Microsoft Office

Travel flexibility

Education

Bachelor's degree

Advanced degree preferred

Tools

RBQM tools

Clinical systems

Data visualization

Analytics dashboards

Job description

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Risk Based Quality Management to lead RBQM strategy and governance across our clinical trial portfolio.

You will partner with Clinical Management, Data Management, Biostatistics, QA, Safety, and vendors to embed a data-driven oversight model aligned with global regulations. You will guide risk assessment, mitigation, and analytics, ensuring inspection readiness, continuous improvement, and regulatory compliance across programs