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- Tasks: Lead compliance and quality in pharmacovigilance systems to ensure patient safety.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive benefits, including health support and a culture of inclusion.
- Other info: Dynamic role with opportunities for professional growth and collaboration.
- Why this job: Make a real impact on global health by ensuring drug safety and compliance.
- Qualifications: Science degree and experience in pharmaceutical PV or GxP Quality Assurance required.
The predicted salary is between 60000 - 80000 £ 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.
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.
PV Systems and Processes Lead x2 in Winnersh employer: CSL Seqirus
Contact Detail:
CSL Seqirus Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land PV Systems and Processes Lead x2 in Winnersh
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at CSL or similar companies. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by diving deep into CSL's values and recent projects. Show us that you’re not just another candidate; you’re genuinely interested in what we do and how you can contribute.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about your past experiences and how they’ve shaped you into the perfect fit for the PV Systems & Processes Lead role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re serious about joining the CSL team.
We think you need these skills to ace PV Systems and Processes Lead x2 in Winnersh
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the PV Systems & Process Lead role. Highlight your regulatory expertise and problem-solving abilities, as these are key to impressing us.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about pharmacovigilance and how your background makes you the perfect fit for our team. Be genuine and let your personality come through.
Showcase Relevant Experience: When detailing your experience, focus on your hands-on work with regulatory inspections and PV audits. We want to see how you've tackled compliance challenges and driven change in previous roles.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows us you’re serious about joining CSL Seqirus!
How to prepare for a job interview at CSL Seqirus
✨Know Your Regulations
Make sure you brush up on GVP regulations, ICH GCP, and any relevant international requirements. Being able to discuss these confidently will show that you’re not just familiar with the rules but can also apply them practically.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified compliance risks and implemented effective CAPA processes in the past. This role is all about practical problem-solving, so demonstrating your experience here will set you apart.
✨Build Relationships
Think about how you can demonstrate your ability to influence across functions and seniority levels. Share stories where you’ve successfully collaborated with different teams to drive change, as this is crucial for the role.
✨Be Inspection Ready
Familiarise yourself with the inspection process and be ready to discuss your experience managing regulatory inspections and PV audits. Highlighting your readiness and proactive approach will resonate well with the interviewers.