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- Tasks: Lead compliance and quality for CSL's pharmacovigilance systems, ensuring safety and regulatory adherence.
- Company: Join CSL Seqirus, a leader in innovative healthcare solutions.
- Benefits: Inclusive culture, career growth, and opportunities to make a real impact.
- Other info: Collaborative team with a focus on innovation and continuous improvement.
- Why this job: Be at the forefront of patient safety and regulatory excellence in a dynamic environment.
- Qualifications: Degree in life sciences 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
- Own the quality and compliance infrastructure that underpins CSL's PV system.
- Provide expert GVP and PV legislation guidance across the organisation, ensuring that regulatory changes translate into timely, concrete action.
- Lead investigation and resolution of deviations and non-compliances, including root cause analysis, CAPA development, and effectiveness tracking.
- Review procedural documents across GCSP, GRA, and GMA for GVP compliance.
- Serve as the primary inspection coordinator for health authority and third-party PV audits in your region from readiness planning through to CAPA close-out.
- Track quality and performance indicators, identifying trends, and escalating risks appropriately.
- Deliver PV quality training and share best practices across functions and affiliates.
- 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. With state-of-the-art production facilities in the U.
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.
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.
Watch our On the Front Line video to learn more about CSL Seqirus.
Process Lead in Maidenhead employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Process Lead in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work 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 mission. Show us how your experience aligns with our commitment to patient safety and compliance. Tailor your answers to reflect our focus on quality and regulatory expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in our minds and shows your enthusiasm for the role.
✨Tip Number 4
Keep an eye on our website for job openings and updates. Applying directly through our site not only shows your interest but also gives you a better chance of being noticed by our hiring team!
We think you need these skills to ace Process Lead in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Process Lead role. Highlight your expertise in pharmacovigilance and regulatory compliance, as these are key to impressing us at CSL.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about patient safety and how your background makes you the perfect fit for this role. Be specific about your achievements in managing audits and inspections.
Showcase Your Problem-Solving Skills: In your application, don’t just list your responsibilities; share examples of how you've tackled compliance risks or led CAPA processes. We love seeing candidates who can demonstrate their practical problem-solving abilities.
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 Behring
✨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 solutions in past roles. This is a key part of the Process Lead position, so demonstrating your ability to drive change will set you apart from other candidates.
✨Build Relationships
Think about how you can demonstrate your communication and leadership skills during the interview. Be ready to share instances where you’ve influenced others across functions or regions, as this will highlight your collaborative approach.
✨Prepare for Inspection Scenarios
Since you'll be coordinating inspections, it’s wise to prepare for questions around managing regulatory inspections and PV audits. Consider discussing your experience with CAPA development and effectiveness tracking to showcase your hands-on expertise.