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.
Requirements
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
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .You Belong at CSLTo learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belongingEqual Opportunity EmployerCSL 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 .Watch our 'On the Front Line' video to learn more about CSL SeqirusHealth insurance
Additional Information
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.
Csl · Seqirus, UK