GVP PV Vendor Quality & Oversight Lead

CSL; Melbourne; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

CSL is seeking a GVP Vendor Oversight and QA Lead to join the newly established VSQA within R&D Quality. You will own the quality oversight of CSL's PV vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management support, medical information and call centre providers.

You will lead the end-to-end PV vendor lifecycle: defining the qualification and risk-based oversight strategy, owning quality agreements, overseeing

Qualifications

• Bachelor's degree in a relevant scientific discipline; postgraduate qualification desirable.
• GVP/PV quality experience with vendor or service provider oversight.
• Experience owning quality agreements and contributing to or leading vendor oversight programmes.
• Knowledge of EU GVP Modules, EU pharmacovigilance legislation, ICH guidance and ALCOA+ data integrity principles.

Responsibilities

• Define and own the risk-based qualification/requalification strategy for PV vendors.
• Lead vendor qualification across paper, remote and onsite assessments.
• Draft, negotiate and maintain Quality Agreements with PV vendors.
• Establish vendor KPIs, SLAs, dashboards and governance forums; set risk-based thresholds.
• Lead vendor reviews; ensure CAPAs are implemented, verified and effective.
• Develop QMS procedures, templates and training for PV vendor oversight.
• Provide input to deviation, complaint, change control and CAPA processes related to PV vendors.

Education

Bachelor's degree in a relevant scientific discipline

Job description

CSL is seeking a GVP Vendor Oversight and QA Lead to join the newly established VSQA within R&D Quality. You will own the quality oversight of CSL's PV vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management support, medical information and call centre providers.

You will lead the end-to-end PV vendor lifecycle: defining the qualification and risk-based oversight strategy, owning quality agreements, overseeing