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. 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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit [https://www.csl.com/](https://www.csl.com/) and CSL Plasma at [https://www.cslplasma.com/](https://www.cslplasma.com/). **Our Benefits** For more information on CSL benefits visit [How CSL Supports Your Well-being | CSL](https://www.csl.com/careers/your-well-being). **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 [https://www.csl.com/accessibility-statement](https://www.csl.com/accessibility-statement). **Watch our ‘On the Front Line’ video to learn more about CSL Seqirus**