Remote Lead, Risk-Based Quality Management

Otsuka America Pharmaceutical Inc.; Little Rock (AR); Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

401(k) match

Tuition reimbursement

Student loan assistance

Flexible time off

Paid holidays and leave

Job summary

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

You will partner with Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, and CROs to embed a data‑driven oversight model aligned with global regulatory expectations. The role focuses on risk assessment, mitigation, and analytics to drive proactive quality management, with a leadership stance

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Minimum 8 years in pharma/biotech, trial/clinical operations or RBQM.
• Experience with risk‑based quality management and centralized monitoring.
• Leadership in implementing RBQM in global trials.
• Familiarity with ICH guidelines and global regulatory expectations.
• Strong cross‑functional communication and problem‑solving.
• Proficiency with RBQM tools, clinical systems, data dashboards, and analytics.

Responsibilities

• Lead RBQM strategy, governance, processes, tools, and performance metrics.
• Drive risk‑based approaches across the trial lifecycle and oversight.
• Serve as RBQM expert in cross‑functional forums, audits, and inspections.
• Oversee risk identification, evaluation, and study‑level tolerance limits.
• Monitor KPIs and quality signals across portfolios for mitigation.
• Partner with departments to ensure centralized monitoring and data‑driven decisions.
• Lead process improvements and digital tool integration for RBQM.
• Ensure compliance with regulatory requirements and inspection readiness.
• Oversee external service providers and vendor collaboration.
• Support budgeting, cost management, and financial accountability.

Skills

Leadership

RBQM expertise

Cross-functional collaboration

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

RBQM tools

Clinical systems

Analytics dashboards

Data visualization

Job description

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

You will partner with Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, and CROs to embed a data‑driven oversight model aligned with global regulatory expectations. The role focuses on risk assessment, mitigation, and analytics to drive proactive quality management, with a leadership stance