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- Tasks: Lead compliance and quality for CSL's global pharmacovigilance systems.
- Company: Join CSL Seqirus, a leader in influenza vaccine production.
- Benefits: Enjoy competitive benefits and a culture of inclusion.
- Other info: Dynamic role with opportunities for growth and innovation.
- Why this job: Make a real impact on patient safety and regulatory compliance.
- Qualifications: Science degree and experience in pharmacovigilance or quality assurance required.
The predicted salary is between 55000 - 65000 £ 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 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
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at CSL or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨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 patient safety and how you can contribute to our mission.
✨Tip Number 3
Practice your problem-solving skills! Be ready to discuss real-life scenarios where you've tackled compliance issues or led audits. We love hearing about your hands-on experience!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, we’re always on the lookout for talent that fits our culture.
We think you need these skills to ace PV Systems and Processes Lead x2
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of PV Systems and Processes Lead. Highlight your experience in pharmacovigilance and regulatory compliance, and don’t forget to showcase any relevant achievements that demonstrate your problem-solving skills.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that align with the job description, especially around managing regulatory inspections and CAPA processes.
Showcase Your Communication Skills: Since this role involves influencing across various functions and seniority levels, make sure to highlight your communication skills. Use clear and concise language in your application to reflect your ability to convey complex information effectively.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets the attention it deserves, and you’ll be one step closer to 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. 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 you drove change effectively.
✨Build Relationships
Since this role involves influencing across various functions and seniority levels, think about how you’ve successfully built relationships in previous roles. Be ready to share specific instances where your communication skills made a difference.
✨Prepare for Audits
As the primary inspection coordinator, you’ll need to demonstrate your experience with regulatory inspections and PV audits. Familiarise yourself with common audit questions and be prepared to discuss how you ensure readiness and follow-up on CAPA close-outs.