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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: Comprehensive benefits package focused on your well-being and professional growth.
- Other info: Be part of a diverse team that values inclusion and innovation.
- Why this job: Make a real impact in patient safety while driving regulatory excellence.
- Qualifications: Degree in life sciences and experience in pharmacovigilance or quality assurance.
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 Wells 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 Wells
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those already at CSL. A friendly chat can open doors and give you insider info on what they're really looking for.
✨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 how you can contribute to our mission.
✨Tip Number 3
Practice your STAR technique for answering competency questions. We want to hear about your past experiences and how they relate to the role, so be ready to share specific examples!
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can leave a lasting impression and shows us that you’re keen on the opportunity.
We think you need these skills to ace PV Systems and Processes Lead x2 in Wells
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 in your role.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified compliance risks and implemented effective CAPA processes in the past. This will demonstrate your ability to lead investigations and drive change, which is crucial for this position.
✨Build Relationships
Think about how you can illustrate your communication and leadership skills during the interview. Be ready to share instances where you’ve influenced cross-functional teams or managed stakeholders effectively, as this is key to thriving in this role.
✨Prepare for Audits
Since you'll be serving as the primary inspection coordinator, it’s important to discuss your experience with regulatory inspections and PV audits. Prepare to talk about your approach to readiness planning and how you ensure compliance throughout the audit process.