PV Systems and Processes Lead x2 page is loaded## PV Systems and Processes Lead x2locations: Seqirus UK - Maidenheadtime type: Vollzeitposted on: Heute ausgeschriebenjob requisition id: R-274200**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.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 affiliatesYou'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.To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at .**Our Benefits**For more information on CSL benefits visit .**You Belong at CSL**At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging**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 .**Watch our ‘On the Front Line’ video to learn more about CSL Seqirus**
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