Senior RBQM Leader: Risk-Based Quality Management

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an experienced Associate Director of Risk Based Quality Management to lead RBQM strategy across the clinical portfolio.

This remote, full-time role partners with Clinical Management, Data Management, Biostatistics, QA, Safety, and external vendors to embed a data-driven risk oversight model that aligns with global regulatory expectations. The ideal candidate has 8+ years in RBQM within pharma/biotech, solid regulatory knowledge (ICH/GCP), and

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 8+ years in pharmaceutical/biotech trial operations or RBQM.
• Strong RBQM, centralized monitoring, and data analytics experience.
• Global regulatory familiarity (ICH/E6, E8; GCP).
• Proven leadership in global RBQM implementation.

Responsibilities

• Lead RBQM strategy, governance, and operating model across trials.
• Drive risk-based oversight from protocol design to closeout.
• Partner across functions to embed data-driven RBQM decisions.
• Oversee risk assessment, KRIs/QTLs, and deviation escalations.
• Ensure regulatory inspection readiness and CAPA handling.
• Manage external CROs/vendors to align with RBQM goals.
• Monitor budgets and vendor performance; drive cost efficiency.
• Support training and change management for RBQM adoption.

Skills

RBQM

Risk management

Data analytics

Regulatory compliance

Stakeholder collaboration

Leadership

Change management

RBQM tools

Clinical systems

Data visualization

Education

Bachelor's in life sciences

Advanced degree preferred

Tools

RBQM tools

Clinical systems

Data visualization platforms

Analytics dashboards

Job description

Otsuka America Pharmaceutical Inc. is seeking an experienced Associate Director of Risk Based Quality Management to lead RBQM strategy across the clinical portfolio.

This remote, full-time role partners with Clinical Management, Data Management, Biostatistics, QA, Safety, and external vendors to embed a data-driven risk oversight model that aligns with global regulatory expectations. The ideal candidate has 8+ years in RBQM within pharma/biotech, solid regulatory knowledge (ICH/GCP), and