At a Glance
- Tasks: Lead compliance and quality for CSL's pharmacovigilance systems, ensuring safety and regulatory adherence.
- Company: Join CSL Seqirus, a leader in innovative healthcare solutions.
- Benefits: Enjoy a hybrid work model, competitive salary, and a focus on inclusion and belonging.
- Other info: Be part of a team that values innovation and collaboration across global operations.
- Why this job: Make a real impact on patient safety while developing your career in a dynamic environment.
- Qualifications: Degree in life sciences and experience in pharmacovigilance or quality assurance required.
The predicted salary is between 51750 - 63250 £ per year.
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 do
- You'll own the quality and compliance infrastructure that underpins CSL's PV system.
- 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. With state-of-the-art production facilities in the U.
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.
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.
Summary Location: Seqirus UK - Maidenhead Type: Full time
Process Lead in Maidenhead employer: CSL
CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.
