PV Systems and Processes Lead x2 in Hinchley Wood
PV Systems and Processes Lead x2

PV Systems and Processes Lead x2 in Hinchley Wood

Hinchley Wood Full-Time 60000 - 80000 £ / year (est.) No home office possible
CSL Seqirus

At a Glance

  • 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 in healthcare.
  • Why this job: Make a real impact on global health by ensuring drug safety and compliance.
  • 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

About CSL Seqirus: CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus.

PV Systems and Processes Lead x2 in Hinchley Wood employer: CSL Seqirus

CSL Seqirus is an exceptional employer that prioritises patient safety and regulatory compliance within a dynamic work environment. With a strong commitment to inclusion and belonging, employees are encouraged to thrive through continuous learning and development opportunities, while contributing to global health initiatives. Located in state-of-the-art facilities, team members enjoy a collaborative culture that values diverse perspectives and fosters innovation.
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 Hinchley Wood

✨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 & Processes 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 at CSL.

We think you need these skills to ace PV Systems and Processes Lead x2 in Hinchley Wood

GVP Regulations
ICH GCP
Pharmacovigilance (PV)
Quality Assurance (GxP)
Regulatory Compliance
Deviation Management
CAPA Development
Root Cause Analysis
Inspection Coordination
Training Delivery
Communication Skills
Leadership Skills
Analytical Skills
Relationship Building
Problem-Solving Skills

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 being noticed. It’s the easiest way for us to keep track of your application and ensure it gets to 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 identified compliance risks and implemented solutions in past roles. This is a key part of the job, so demonstrating your ability to tackle challenges head-on will impress the interviewers.

✨Be Ready for Scenario Questions

Expect questions that ask how you would handle specific situations, like a regulatory inspection or a deviation. Think through your responses ahead of time, focusing on your thought process and the steps you would take to resolve issues.

✨Highlight Your Communication Skills

Since this role involves influencing across various functions and seniority levels, be prepared to discuss how you've effectively communicated complex information in the past. Share examples that showcase your ability to build relationships and drive change.

PV Systems and Processes Lead x2 in Hinchley Wood
CSL Seqirus
Location: Hinchley Wood

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