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- Tasks: Lead compliance and quality for CSL's global pharmacovigilance systems.
- Company: Join CSL Seqirus, a leader in innovative healthcare solutions.
- Benefits: Inclusive culture, career growth, and opportunities to make a real impact.
- Other info: Dynamic role with a focus on collaboration and continuous improvement.
- Why this job: Be at the forefront of patient safety and 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
- 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. To learn more about inclusion and belonging visit.
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.
Innovation Process Lead in Maidenhead employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Innovation Process Lead in Maidenhead
✨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 diving deep into CSL's values and recent projects. Show us that you’re not just another candidate; you’re someone who genuinely cares about patient safety and compliance.
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. We want to hear about your past experiences in a structured way, so we can see how you tackle challenges and drive change.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re serious about joining the CSL team.
We think you need these skills to ace Innovation Process Lead in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the role of Innovation Process Lead. Highlight your experience in pharmacovigilance and regulatory compliance, and don’t forget to showcase those problem-solving skills that we’re looking for!
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 genuine and let your personality come through.
Showcase Relevant Experience: When filling out your application, focus on your hands-on experience with regulatory inspections and PV audits. We want to see how you've tackled challenges in the past and what you learned from them.
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. Plus, you’ll find all the details you need about the role and our company culture there!
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.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified compliance risks and implemented solutions in past roles. This is your chance to demonstrate your ability to drive change and improve processes, which is crucial for the Innovation Process Lead position.
✨Build Relationships
Think about how you can build rapport with different teams and stakeholders. During the interview, highlight your communication and leadership skills, as these will be key in influencing across functions and regions.
✨Be Inspection Ready
Familiarise yourself with the inspection process and be ready to discuss your experience managing regulatory inspections and PV audits. Showing that you understand what it takes to be inspection-ready will set you apart from other candidates.