GVP Vendor Oversight and QA Lead (EU)

About the role

This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management, medical information and call centre providers. You will lead the end-to-end PV vendor lifecycle: defining qualification and risk-based oversight strategy, owning quality agreements, overseeing CAPAs, and driving issue management and continuous improvement, ensuring adherence to GVP, data integrity and applicable PV regulations. You will be the senior quality point of contact for PV vendor matters, partnering with and influencing relevant stakeholders.

What you will do

• Define and own the risk-based qualification and requalification strategy for PV vendors, and own the negotiation and maintenance of Quality Agreements.
• Establish vendor KPIs, SLAs, dashboards and governance forums, and lead periodic reviews to hold vendors accountable and ensure CAPAs are implemented, verified and effective.
• Lead PV inspection readiness for vendor-related scope, including front and back room support and storyboard development.
• Set the quality standards expected of PV vendors against GVP, ICH, GVP Modules and ALCOA+; own the QMS procedures, templates and training governing PV vendor oversight; and provide input to deviation, complaint, change control and CAPA processes.
• Lead risk assessments, set controls and monitoring frequency based on risk, and analyse trends across audit findings, deviations and complaints to inform management reviews.
• Maintain expert knowledge of GVP regulations and PV industry trends, and act as the internal reference point.

• 3+ years of GVP or PV quality experience, including direct pharmacovigilance vendor or service-provider oversight.
• Track record of owning quality agreements and contributing to a vendor oversight programme.
• Working knowledge of audit and inspection management processes. You will not conduct audits, but you will need to assess audit findings, review CAPA adequacy and own effectiveness checks.
• Demonstrated knowledge of GVP Modules, EU pharmacovigilance legislation, ICH guidance and ALCOA+ data integrity principles.
• Strong communication, influencing and negotiation skills at stakeholder and vendor level.
• Ability to work autonomously.
• Bachelor's degree in a relevant scientific discipline; postgraduate qualification desirable.