PV Systems and Processes Lead Quality Assurance CSL Seqirus Berkshire, United Kingdom R-Posted
Listed on 2026-09-13
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
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.
This position is to be hybrid (3 days a week on‑site) at our office in Maidenhead
What you'll doYou’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
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