Director, Quality Risk Management (Global R&D & Pharmacovigilance QA)

A leading global pharmaceutical organization is seeking a Director of Quality Risk Management (QRM) to lead and evolve a best-in-class, science-driven risk framework across R&D, Pharmacovigilance, and Medical Affairs.

This is a high-impact leadership role with global visibility, shaping how risk-based decision-making is embedded across the enterprise and ensuring alignment with ICH Q9 (R1), ICH Q10, and global GxP standards.

Your main responsibility will be to:

• Lead the design and governance of a global QRM framework across R&D and PV
• Provide independent QA oversight on risk identification, assessment, and mitigation
• Drive risk-based decision-making across cross-functional stakeholders
• Embed QRM into core QMS processes (CAPA, audits, change control, vendor management)
• Deliver executive-level risk insights, dashboards, and trend analytics
• Support inspection readiness, regulatory interactions, and audit responses
• Champion quality culture and capability building across global teams

To be shortlisted for the role, you would ideally come with:

• 10+ years in GxP Quality / QA / Compliance within pharma/biotech
• Strong experience in Quality Risk Management frameworks (ICH Q9)
• Exposure across R&D, Pharmacovigilance (GVP), Clinical (GCP)
• Proven ability to operate at a global, cross-functional leadership level
• Experience supporting regulatory inspections and audits
• Strong stakeholder management with the ability to influence without authority
• Experience with digital QMS, risk analytics, or dashboards is a plus

AM
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112