Remote RBQM Strategy Lead

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

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 lead governance, risk assessment, and data‑driven oversight to ensure compliant, inspection‑ready trials.

Role requires collaboration with Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs, with a focus on proactive risk detection and mitigation aligned to global regulatory expectations.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Experience with risk-based quality management and centralized monitoring.
• Familiar with ICH E6(E2) and global regulatory expectations.

Responsibilities

• Lead RBQM strategy, governance, and metrics across trials.
• Oversee risk assessment, mitigation, and study‑level KPIs.
• Partner across departments to ensure data‑driven decision making and compliance.

Skills

RBQM knowledge

Cross-functional collaboration

Regulatory awareness

Data analytics

Education

Bachelor’s in life sciences

Advanced degree preferred

Tools

RBQM tools

Analytics dashboards

Clinical systems

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 lead governance, risk assessment, and data‑driven oversight to ensure compliant, inspection‑ready trials.

Role requires collaboration with Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs, with a focus on proactive risk detection and mitigation aligned to global regulatory expectations.