Director, Quality Risk Management (Global R&D & Pharmacovigilance QA)
Full-time
Director/C-Level
2 months ago
A leading global pharmaceutical organization is seeking aDirector of Quality Risk Management (QRM) to lead and evolve a best-in-class,science-driven r.....
A leading global pharmaceutical organization is seeking aDirector of Quality Risk Management (QRM) to lead and evolve a best-in-class,science-driven risk framework across R&D, Pharmacovigilance, and MedicalAffairs.
This is a high-impact leadership role with globalvisibility, shaping how risk-based decision-making is embedded across theenterprise and ensuring alignment with ICH Q9 (R1), ICH Q10, and global GxPstandards.
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
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