Remote Associate Director, Risk‑Based Quality Oversight

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

Benefits offered by this job

Medical benefits

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Risk Based Quality Management to lead RBQM strategy across the clinical trial portfolio.

You will drive governance, risk assessment, and analytics to ensure proactive detection and mitigation of operational and data quality risks. In this remote role, you will partner with Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs to embed a data-driven oversight model aligned with ICH/FDA expectations and inspection

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 8+ years in pharma/biotech, RBQM or related clinical Ops.
• Strong RBQM, centralized monitoring, and data analytics experience.
• Global/regulatory experience (ICH/GCP) and cross-functional leadership.

Responsibilities

• Develop RBQM operating model governance including risk frameworks and performance metrics.
• Lead risk identification, evaluation and escalation at study and portfolio levels.
• Oversee centralized monitoring strategies and data-driven decision making.
• Drive continuous RBQM process improvements and digital tool integration.
• Ensure CRO/vendor alignment with RBQM requirements and oversight.
• Support audit, inspection readiness, CAPA, and regulatory responses.

Skills

RBQM

Centralized monitoring

Data analytics

Leadership

Cross-functional collaboration

Education

Bachelors in life sciences

Advanced degree preferred

Tools

RBQM tools

Clinical systems

Data viz platforms

Analytics dashboards

Job description

Otsuka America Pharmaceutical Inc. seeks an Associate Director, Risk Based Quality Management to lead RBQM strategy across the clinical trial portfolio.

You will drive governance, risk assessment, and analytics to ensure proactive detection and mitigation of operational and data quality risks. In this remote role, you will partner with Clinical Management, Data Management, Biostatistics, QA, Safety, and CROs to embed a data-driven oversight model aligned with ICH/FDA expectations and inspection