Global Quality Risk Director, R&D & PV QA

DAIICHI SANKYO SINGAPORE PTE. LTD.; Singapore; Presencial; SGD 230.000 - 360.000; Jornada completa

Descripción de la vacante

DAIICHI SANKYO SINGAPORE PTE. LTD.

is seeking a Director, QRM, Global QMS, R&D & PV QA to establish and continuously advance a robust, science- and risk-based Quality Risk Management framework across R&D, Clinical Safety Pharmacovigilance, Medical Affairs and related QMS. You will lead governance, oversight, and strategic direction to ensure risks are identified, assessed, controlled, communicated, and reviewed in alignment with ICH Q9 (R1), ICH Q10, and global regulatory expectations.

Formación

• Bachelor or higher in a science domain; advanced degree preferred.
• Minimum 8–12+ years in pharmaceutical quality/GxP with global scope.
• Experience establishing global QRM framework with ICH Q9 (R1) and Q10.

Responsabilidades

• Lead design and governance of global QRM framework across R&D, PV, MA and QA systems.
• Provide independent QA oversight for risk assessment and lifecycle activities.
• Embed QRM outputs into QE, CAPA, change control, supplier oversight and QMS reviews.
• Develop digital QRM dashboards and metrics for senior management.
• Monitor regulatory expectations and oversee inspection readiness and responses.
• Influence cross-functional teams to integrate risk-based thinking across functions.

Conocimientos

Global QA leadership

Quality risk management

Regulatory inspections readiness

Stakeholder management

Strategic risk governance

Educación

Bachelor's degree in Life Sciences/Pharmacy or related

Advanced degree (PhD/ PharmD/ MSc/ MPH/ MBA) preferred

Herramientas

QRM tools & templates

Descripción del empleo

DAIICHI SANKYO SINGAPORE PTE. LTD.

is seeking a Director, QRM, Global QMS, R&D & PV QA to establish and continuously advance a robust, science- and risk-based Quality Risk Management framework across R&D, Clinical Safety Pharmacovigilance, Medical Affairs and related QMS. You will lead governance, oversight, and strategic direction to ensure risks are identified, assessed, controlled, communicated, and reviewed in alignment with ICH Q9 (R1), ICH Q10, and global regulatory expectations.