PV Systems and Processes Lead x2

PV Systems & Process Lead

Patient safety depends on pharmacovigilance systems that work — and work well. In this role, you’ll be at the centre of keeping CSL’s global PV system compliant, continuously improving, and inspection‑ready across Global Clinical Safety & Pharmacovigilance, Global Regulatory Affairs, Global Medical Affairs, affiliates, and commercial operations.

What You’ll Do

• Provide expert GVP and PV legislation guidance across the organization, ensuring regulatory changes translate into timely, concrete action.
• Lead investigation and resolution of deviations and non‑compliances, including root‑cause analysis, CAPA development, and effectiveness tracking.
• Review procedural documents across GCSP, GRA, and GMA for GVP compliance.
• Serve as the primary inspection coordinator for health authority and third‑party PV audits in your region — from readiness planning through to CAPA close‑out.
• Track quality and performance indicators, identify trends, and appropriately elevate risks.
• Deliver PV quality training and share best practices across functions and affiliates.

What You’ll Bring

• A science or life sciences degree (or equivalent through experience) and significant experience in the pharmaceutical industry — mainly in PV or GxP Quality Assurance.
• Hands‑on experience managing regulatory inspections and PV audits.
• Strong command of GVP regulations, ICH GCP, and relevant international requirements.
• Proven ability to lead deviation and CAPA management processes.
• Strong communication and leadership skills to influence across functions, regions, and seniority levels.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

#J-18808-Ljbffr…