PV Systems and Processes Lead x2 in Maidenhead

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.

This is a role for someone who thrives at the intersection of regulatory expertise and practical problem-solving — someone who can spot a systemic compliance risk, build the relationships to address it, and drive the change that makes it stick.

What you'll do

• You'll own the quality and compliance infrastructure that underpins CSL's PV system. Day-to-day, that means:
• Providing expert GVP and PV legislation guidance across the organisation, and ensuring that regulatory changes translate into timely, concrete action
• Leading investigation and resolution of deviations and non-compliances, including root cause analysis, CAPA development, and effectiveness tracking
• Reviewing procedural documents across GCSP, GRA, and GMA for GVP compliance
• Serving as the primary inspection coordinator for health authority and third-party PV audits in your region — from readiness planning through to CAPA close-out
• Tracking quality and performance indicators, identifying trends, and escalating risks appropriately
• Delivering PV quality training and sharing best practices across functions and affiliates

You'll also contribute to the broader audit programme and help shape the long-term PV audit strategy, in line with GVP Module IV.

What you'll bring

• A science or life sciences degree (or equivalent through experience), plus 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
• The communication and leadership skills to influence across functions, regions, and seniority levels

About CSL Seqirus: CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.