Job Summary

This position provides strategic direction for and oversight of the Risk Based Quality Management (RBQM) principles that support the Company's vision including elements to achieve a Quality by Design and Quality Risk Management approach to clinical trial processes and procedures.

Job Description

Responsibilities

RBQM Vision and Strategy: Provides strategy and leads implementation of vision for risk based quality management within impacted Daiichi Sankyo functions globally and with external parties as required.

• Champions the ‘Quality by Design’ and Quality Risk Management approaches to quality management within Daiichi Sankyo and works to develop a culture that supports these approaches.
• Create and implement vision for Daiichi Sankyo RBQM future state including operating model, processes, resource requirements, and supportive technology (as needed).
• Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
• Aligns the Clinical Risk Manager resources to meet the needs for assisting with the development and implementation of that vision and ensure adequate resourcing for Daiichi Sankyo portfolio of studies.
• Monitors external environment and incorporates RBQM industry benchmarking, best practices, and emerging solutions within Daiichi Sankyo.

Oversee Development and Implementation of RBQM Standards, Tools and Training

• Ensure Daiichi Sankyo RBQM practices comply with industry regulations / updates (e.g. new requirements), including conduct of impact assessments and implementation of changes as required.
• Lead development and maintenance of RBQM standards such as guiding principles, risk, and quality tolerance limit (QTL) libraries.
• Lead RBQM Center of Excellence, ensure optimal utilization of the cross functional SMEs to embed RBQM across portfolio of studies and ensure adoption.
• Develop and implement tools to maximize the consistency, effectiveness, and efficiency of the RBQM processes across Daiichi Sankyo compounds with a focus on oversight, lessons learned and inspection readiness.
• Lead assessment of training needs and ensure delivery of RBQM Training with Learning and Development team members.
• Lead development and implementation of process improvement initiatives related to RBQM to improve quality and ensure patient safety and data quality and integrity.
• Establish, measure, analyze and report on RBQM related metrics and present outputs to Leadership and Management to drive RBQM Implementation.

Oversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness.

• Review and determine acceptability of CRO / vendor RBQM practices and associated tools with Daiichi Sankyo standards.
• Participate in CRO / vendor governance, ensure oversight of provider RBQM processes and tools and work collaboratively with partners to develop RBQM approaches.
• Act as issue escalation point for study teams and clinical risk managers related to RBQM and ensure timely and thorough problem resolution as required.

Responsibilities Continued

Qualifications

Education Qualifications

• Bachelor's degree required. Degree in a scientific or life sciences discipline preferred.

Experience Qualifications

• Bachelor's degree and 10 years of relavent pharmaceutical industry or Clinical Research Organization experience or Master's degree and 8 years of relavent pharmaceutical industry or Clinical Research Organization experience required.
• 4+ years of clinical study monitoring experience and advanced knowledge of risk based quality management required.
• Experience in Quality by Design principles; Quality Risk Identification and Management processes; root cause analysis; process mapping preferred

Travel Requirements
Ability to travel up to 10% of the time. Hybrid position that may require occasional travel (global).