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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 growth in a supportive environment.
- 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
PV Systems and Processes Lead x2 in Uxbridge 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 Uxbridge
✨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 competency questions. We love hearing about your past experiences, so structure your answers to highlight your skills and achievements clearly.
✨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 Uxbridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the job description. Highlight your expertise in pharmacovigilance and regulatory compliance, as these are key for the PV Systems & Process Lead role.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're the perfect fit for this role. Share specific examples of how you've tackled compliance issues or led successful audits in the past. This is your chance to show off your problem-solving skills!
Showcase Your Communication Skills: Since this role involves influencing across various functions, make sure to demonstrate your communication prowess in your application. Use clear, concise language and provide examples of how you've effectively communicated complex regulatory information.
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 our team at CSL!
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 PV audits. Discuss how you prepared for these events and what strategies you used to ensure compliance and readiness.