Associate Director - Risk Based Quality Management, Risk Based Quality Management

The Associate Director, Risk Based Quality Management is responsible for developing, implementing and optimizing RBQM frameworks across the clinical trial portfolio. This role ensures proactive detection, assessment, and mitigation of operational, data quality, and patient safety risks, enabling efficient, compliant, and inspection ready trial execution. The Senior Manager partners across Clinical Management, Data Management, Biostatistics, Quality Assurance, Safety, and external vendors to embed a data driven, risk proportionate oversight model that aligns with global regulatory expectations (e.g. ICH E6(R3), E8(R1), FDA, EMA).

Key Responsibilities:

RBQM Strategy & Governance

• Lead the development, enhancement, and governance of the RBQM operating model, including risk frameworks, processes, tools, and performance metrics.
• Drive adoption of risk‑based approaches across the trial lifecycle—from protocol design and risk assessment to study conduct oversight and closeout.
• Serve as the subject matter expert representing RBQM in cross‑functional forums, audits, and regulatory inspections.

Risk Assessment & Mitigation

• Provide guidance regarding and/or facilitate cross‑functional risk identification and evaluation (e.g., KRIs, QTLs, operational/process risks) at study, program, and portfolio levels.
• Oversee creation, review, and maintenance of study‑level Quality Tolerance Limits and provide oversight of timely evaluation and escalation of deviations.
• Develop, in conjunction with applicable stakeholders, Risk Management and Sponsor Oversight Plan(s) to outline holistic approach to RBQM and oversight activities in support of trial conduct risk mitigation strategies.
• Monitor key risk indicators and performance metrics to identify emerging trends, quality signals, and potential compliance issues from a portfolio perspective.

Operational Oversight & Analytics

• Partner with Clinical Management, Monitoring Oversight, Data Sciences, and other applicable departments to ensure effective centralized monitoring strategies and data‑driven decision‑making.
• Oversee analytical reviews of operational and clinical data to support proactive quality management.
• Lead cross‑functional data reviews to confirm risk controls are effective and adjustments are implemented when needed.

Process Improvement & Innovation

• Drive continuous improvement initiatives to increase efficiency, standardization, and quality in RBQM processes.
• Champion the integration of digital tools, analytics platforms, and automation to enhance risk detection and oversight.
• Support change management and training strategies to embed RBQM across the organization.

Stakeholder & Vendor Collaboration

• Ensure alignment and compliance of CROs and vendors with RBQM requirements and expectations.
• Provide strategic direction and guidance to internal teams and external partners on RBQM methodologies and best practices.

Regulatory Compliance & Inspection Readiness

• Ensure RBQM processes meet global regulatory requirements, industry standards, and internal quality frameworks.
• Lead or contribute to audit and inspection preparation, responses, CAPA development, and remediation activities related to RBQM.

Oversight of External Service Providers

• Provide operational oversight of external service providers (e.g., CROs/FSPs, consultants, vendors) involved in the execution of applicable operational activities.
• Ensure external partners are aligned with objectives, timelines, and quality standards through regular communication, performance monitoring, and issue resolution.
• Participate in vendor selection, contract negotiation, and scope definition to ensure optimal service delivery and cost-effectiveness.
• Monitor adherence to contractual obligations, KPIs, and regulatory requirements, escalating concerns as needed to ensure compliance and mitigate risk.
• Foster collaborative relationships with external partners to promote transparency, accountability, and continuous improvement in service delivery.

Financial Management

• Support the development and management of clinical operations budgets, ensuring alignment with project scope, timelines, and strategic priorities.
• Monitor expenditures across assigned activities and vendors to ensure cost-effectiveness and adherence to approved budgets.
• Identify opportunities for cost optimization without compromising quality or compliance.
• Collaborate with Finance and Procurement teams to ensure accurate forecasting, timely invoicing, and resolution of financial discrepancies.
• Provide input into vendor contract negotiations and change orders to ensure financial accountability and transparency.
• Maintain financial documentation and reporting in accordance with corporate policies and audit requirements.

People Management & Staff Development (as applicable)

• Lead onboarding and training for new team members.
• Ensure compliance with SOPs, policies, and training requirements.
• Provide tools and resources to support effective performance.
• Conduct performance reviews and provide coaching and development plans.
• Monitor workload and quality metrics to ensure team performance meets expectations.

• Bachelor’s degree in life sciences or related field, advanced degree preferred.
• Minimum 8 years of experience in the pharmaceutical/biotechnology industry, preferably within Trial/Clinical Operations or related function associated with RBQM activities.
• 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.
• Skilled in interpreting clinical and operational data to identify trends and quality signals.
• Excellent cross‑functional communication, facilitation, and influencing skills.
• Ability to manage multiple priorities and drive decisions in a fast‑paced environment.
• Proficiency with RBQM tools, clinical systems, data visualization platforms, and analytics dashboards.
• Skilled in change leadership and process transformation.
• Strategic and systems-based thinker with strong planning, organizational, analytical, and problem-solving skills.
• Strong collaborator with a solution-oriented mindset.
• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Willingness to travel as required.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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Disclaimer: 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

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