At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Purpose of the function
LOCATION: SWITZERLAND
The Director, Quality Risk Management (QRM), Global QMS, R&D and PV QA leads the development and continuous improvement of a global, science- and risk-based Quality Risk Management framework across R&D, Pharmacovigilance, Medical Affairs, and associated quality systems. The role provides strategic QA oversight to ensure quality risks are proactively identified, assessed, controlled, and monitored in line with global regulatory requirements and company standards. Through cross-functional leadership, the Director drives risk-based decision making, strengthens integration of QRM within the Quality Management System, and promotes a culture of quality, compliance, and continuous improvement.
Roles and Responsibilities
Global Quality Risk Management
- Lead and evolve the global QRM framework across R&D, PV, MA, and associated quality systems.
- Establish standardized risk methodologies, tools, templates, and governance models.
- Define risk management principles and align QRM strategy with enterprise risk management and QMS objectives.
- Drive the QRM roadmap, including digital enablement and process integration.
Risk Oversight & Governance
- Provide independent QA oversight for quality risk assessment, mitigation, communication, and review activities.
- Oversee risks related to processes, systems, vendors, outsourcing, change initiatives, and inspection readiness.
- Ensure risks are proportionate, traceable, inspection-ready, and appropriately escalated.
- Lead governance forums, management review inputs, and cross-functional risk discussions.
Continuous Improvement & Inspection Readiness
- Drive QRM metrics, dashboards, analytics, and continuous improvement initiatives.
- Monitor regulatory trends and translate requirements into QRM practices and standards.
- Support audits, inspections, regulatory interactions, and responses to inspection observations.
Cross-Functional Leadership & Quality Culture
- Partner with global stakeholders across R&D, PV, MA, Regulatory Affairs, IT, Procurement, and Vendor Quality.
- Provide oversight of third-party and vendor risk management activities.
- Champion risk-based thinking through training, coaching, and quality culture initiatives.
Key Deliverables
- Inspection-ready global QRM framework embedded within the Global QMS.
- Standardized and scalable risk management processes and governance models.
- Integrated risk assessments, mitigation plans, and executive risk reporting.
- Effective dashboards, metrics, and analytics supporting proactive decision making.
- Strong organizational capability and adoption of risk-based quality principles.
Education & Experience
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, Engineering, or related scientific discipline required.
- Advanced degree preferred.
Experience
- 8–12+ years of experience in pharmaceutical quality, compliance, QRM, or regulated GxP environments.
- Strong expertise in ICH Q9 (R1), ICH Q10, and global Quality Management Systems.
- Experience supporting inspections, audits, and global cross-functional stakeholder management.
- Experience with vendor oversight and digital quality systems preferred.
Skills and additional Requirements
- Strong expertise in quality risk management and risk-based decision making.
- Strategic thinker with strong analytical and problem-solving skills.
- Ability to influence across global matrix organizations while maintaining QA independence.
- Excellent communication, leadership, and stakeholder management capabilities.
- Commitment to continuous improvement and quality culture development.
