The Director of Quality Risk Management (QRM) at Daiichi Sankyo Singapore is responsible for establishing and overseeing a robust quality risk management framework across R&D, Pharmacovigilance, and Medical Affairs. The role requires strategic leadership, independent QA oversight, and the ability to align with global regulatory standards while fostering a proactive quality culture
Job Summary
This role is accountable for establishing and governing a robust, science-based Quality Risk Management framework across global R&D, Pharmacovigilance, and Medical Affairs.
The incumbent provides independent QA oversight to ensure risks are proactively identified, assessed, controlled, and reviewed in alignment with ICH Q9 (R1) and ICH Q10 standards.
The position requires leading digital enablement efforts to create data-driven dashboards that support proactive risk identification and sustained inspection readiness.
Matching Summary
Match Score: 85
The Director of Quality Risk Management (QRM) at Daiichi Sankyo Singapore is responsible for establishing and overseeing a robust quality risk management framework across R&D, Pharmacovigilance, and Medical Affairs. The role requires strategic leadership, independent QA oversight, and the ability to align with global regulatory standards while fostering a proactive quality culture.
Skills & Requirements
Must-have
ICH Q9 R1 and ICH Q10 compliance expertise
Global Quality Risk Management framework design
Independent QA oversight for R&D and PV
Risk assessment methodology and governance
Regulatory inspection readiness leadership
Nice-to-have
Digital QRM tools and analytics experience
Cross-functional stakeholder influence skills
Vendor and third-party risk management
Proactive quality culture building
Strategic executive-level communication
Key Requirements
8-12+ years pharmaceutical quality or GxP experience
Bachelor's degree in Life Sciences or related field
Advanced degree preferred (PhD, PharmD, MBA)
Demonstrated experience with regulatory inspections