Senior RBQM Leader: Risk-Based Quality Strategy

Biopharma Careers; United States; Remote; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka is seeking an Associate Director of Risk Based Quality Management to develop, implement, and optimize RBQM frameworks across our US clinical trial portfolio. You will partner with Clinical Operations, Data Sciences, and Quality Assurance to embed a data-driven, risk-proportionate oversight model compliant with global expectations.

You will lead governance, risk assessment, and analytics efforts, driving continuous improvements, digital tool adoption, and vendor collaboration while

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Minimum 8 years in pharmaceutical/biotech, preferably within Trial/Clinical Operations or RBQM.
• Strong experience in risk-based quality management, centralized monitoring, or clinical data analytics.
• Demonstrated leadership in implementing RBQM in a global clinical trial setting.
• 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.
• Excellent cross-functional communication, facilitation, and influencing skills.
• Ability to manage multiple priorities and drive decisions in a fast-paced environment.

Responsibilities

• Lead RBQM strategy, governance, and performance metrics.
• Oversee risk assessment, study-level QTLs, and deviation escalation.
• Partner with management and analytics to ensure centralized monitoring.
• Drive process improvements and digital tool integration.
• Coordinate with CROs and vendors to ensure RBQM compliance.
• Support regulatory inspection readiness and CAPA activities.
• Oversee external service providers to ensure quality and cost-effectiveness.
• Assist in budgeting and vendor contract discussions.
• Lead onboarding and training for team members.

Skills

RBQM expertise

Cross-functional leadership

Data analytics

Regulatory knowledge

Change management

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

RBQM tools

Clinical data analytics platforms

Job description

Otsuka is seeking an Associate Director of Risk Based Quality Management to develop, implement, and optimize RBQM frameworks across our US clinical trial portfolio. You will partner with Clinical Operations, Data Sciences, and Quality Assurance to embed a data-driven, risk-proportionate oversight model compliant with global expectations.

You will lead governance, risk assessment, and analytics efforts, driving continuous improvements, digital tool adoption, and vendor collaboration while