Associate Director, RBQM Strategy (Remote)

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

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Associate Director, Risk Based Quality Management to design and optimize RBQM frameworks across the clinical trial portfolio. This role ensures proactive risk detection, assessment, and mitigation to enable compliant, inspection-ready trials.

Collaboration across Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs is essential. You will lead governance, risk assessment, analytics, and process improvements to drive data-driven

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• Minimum 8 years in pharma/biotech, with RBQM or related function experience.
• Strong RBQM, centralized monitoring, or clinical data analytics background.
• Proven leadership implementing RBQM in global trials.
• Familiarity with ICH E6(R2/R3), ICH E8(R1), GCP, and global regulatory expectations.
• Deep understanding of clinical trial processes, operational risk, and data quality principles.
• Ability to interpret clinical/operational data to identify trends and quality signals.
• Excellent cross‑functional communication, facilitation, and influencing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with RBQM tools, clinical systems, data visualization platforms, and analytics dashboards.
• Change leadership and process transformation experience.
• Strategic, analytical, and problem-solving mindset.
• Strong collaboration and solution-oriented approach.
• MS Office proficiency (Outlook, Word, Excel, PowerPoint).
• Willingness to travel as required.

Responsibilities

• Lead RBQM governance, risk frameworks, processes, tools, and performance metrics.
• Drive adoption of risk-based approaches across the trial lifecycle.
• Serve as RBQM SME in cross-functional forums and inspections.
• Guide cross-functional risk identification and evaluation at study/portfolio levels.
• Oversee study-level Quality Tolerance Limits and escalation of deviations.
• Develop risk management and sponsor oversight plans for RBQM.
• Monitor key risk indicators and quality signals.
• Ensure centralized monitoring through data-driven decision making.
• Lead data reviews and confirm effectiveness of risk controls.
• Drive continuous improvement and digital tool integration in RBQM.

Skills

RBQM expertise

Cross-functional leadership

Clinical data analytics

Global RBQM implementation

ICH/GCP knowledge

Data interpretation

Communication skills

Priority management

RBQM tools

Change leadership

Strategic thinking

Collaboration

MS Office

Travel willingness

Education

Bachelor’s degree 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 Associate Director, Risk Based Quality Management to design and optimize RBQM frameworks across the clinical trial portfolio. This role ensures proactive risk detection, assessment, and mitigation to enable compliant, inspection-ready trials.

Collaboration across Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs is essential. You will lead governance, risk assessment, analytics, and process improvements to drive data-driven