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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: Be part of a diverse team driving innovation and patient care.
- Why this job: Make a real impact on global health while advancing your career in a dynamic environment.
- 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
PV Systems and Processes Lead x2 in Islip 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 Islip
✨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 you’re not just another candidate; demonstrate your passion for pharmacovigilance and how you can contribute to our mission.
✨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 & Process 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 you’re serious about joining our team.
We think you need these skills to ace PV Systems and Processes Lead x2 in Islip
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 thriving in this position.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about pharmacovigilance and how your background makes you a great fit for CSL. Be sure to mention any relevant experience with GVP regulations and CAPA management.
Showcase Your Achievements: When detailing your past roles, focus on your achievements rather than just responsibilities. Use metrics where possible to demonstrate how you've improved compliance or led successful audits in previous positions.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people!
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 before the interview. 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 tackled compliance risks or led CAPA processes in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers, making it clear how your actions led to positive outcomes.
✨Build Relationships
Demonstrate your ability to influence across functions and seniority levels. Think of instances where you’ve successfully collaborated with different teams or stakeholders to drive change, and be ready to share those stories.
✨Be Inspection-Ready
Since this role involves being the primary inspection coordinator, highlight your experience with regulatory inspections and audits. Discuss how you prepared for these events and what strategies you used to ensure compliance and readiness.