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- Tasks: Lead compliance and quality for CSL's global pharmacovigilance systems.
- Company: Join CSL Seqirus, a leader in global influenza vaccine production.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Be part of a diverse team that values inclusion 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 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 Great Missenden 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 Great Missenden
✨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 a job description just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your GVP regulations and CAPA management processes. Be ready to share specific examples of how you've tackled compliance issues in the past — it shows you're the real deal!
✨Tip Number 3
Don’t just apply; engage! When you submit your application through our website, follow up with a quick email to express your enthusiasm. It shows initiative and keeps you on their radar.
✨Tip Number 4
Stay updated on industry trends and regulatory changes. Being knowledgeable about the latest in pharmacovigilance will not only help you in interviews but also demonstrate your commitment to the field.
We think you need these skills to ace PV Systems and Processes Lead x2 in Great Missenden
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 your hands-on experience with regulatory inspections and CAPA management.
Showcase Your Communication Skills: Since this role requires strong communication and leadership skills, make sure to highlight instances where you've influenced change or collaborated across functions. We want to see how you can build relationships and drive compliance 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 find all the details you need right there!
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.