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- Tasks: Lead global quality and compliance for pharmacovigilance systems and ensure regulatory adherence.
- Company: Dynamic pharmaceutical company focused on safety and compliance.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on strategic development and operational excellence.
- Why this job: Make a significant impact on patient safety and regulatory excellence in a leadership role.
- Qualifications: 10+ years in pharmaceutical quality assurance with strong leadership and regulatory knowledge.
The predicted salary is between 80000 - 100000 £ per year.
The Head of Pharmacovigilance and Regulatory Quality Assurance leads the global quality and compliance function for our pharmacovigilance system. You are the independent quality authority ensuring that our end-to-end PV processes across clinical safety, regulatory affairs, and medical affairs remain compliant with global regulations, ICH guidelines, and company standards.
Your role bridges strategic oversight with hands-on operational leadership: you design the audit strategy and governance framework that keeps the system fit for purpose, but you also own the day-to-day quality assurance of how PV actually works across the business. You will direct both the strategic evolution of the PVRQA function and its operational delivery. This means setting the long-term compliance roadmap while simultaneously managing inspections, deviation management, and the practical quality controls that keep the system sound.
You partner with senior leadership on strategic direction, but you're equally engaged in the details that matter—ensuring SOPs are fit for purpose, CAPA workflows are rigorous, and systems are inspection-ready.
The Role
You will direct the strategic development of the Global PVRQA function, supporting both the global R and delivering annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors.
Industry Tenure: 10+ years of pharmaceutical industry experience specifically within Quality Assurance.
Leadership Track Record: Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.
Technical Mastery: Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research.
Global Perspective: Experience working within global, cross-functional teams and managing complex regulatory interactions.
Leadership Attributes
- Strategic Acumen: The ability to quickly analyze complex circumstances and drive appropriate decisions and actions.
- Communication: Effective communication skills are essential for this role.
Head of Pharmacovigilance and Regulatory Quality Assurance employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Pharmacovigilance and Regulatory Quality Assurance
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or attend relevant events. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GVP/GCP regulations and pharmacovigilance processes. We recommend practising common interview questions with a friend or in front of the mirror to boost your confidence.
✨Tip Number 3
Showcase your leadership skills during interviews. Be ready to discuss your experience in managing audits and inspections, as well as how you've driven compliance in previous roles. We want to see that strategic acumen in action!
✨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, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Head of Pharmacovigilance and Regulatory Quality Assurance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in pharmacovigilance and regulatory quality assurance. We want to see how your background aligns with the specific requirements of the role, so don’t be shy about showcasing your relevant skills and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for the Head of Pharmacovigilance and Regulatory Quality Assurance role. We love seeing passion and personality, so let us know what excites you about this opportunity and how you can contribute to our team.
Showcase Your Leadership Experience: Since this role involves strategic oversight and operational leadership, make sure to highlight your previous leadership roles. We want to see examples of how you've successfully managed teams and projects, especially in the context of quality assurance and compliance.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at CSL
✨Know Your Regulations Inside Out
Make sure you brush up on GVP/GCP regulations and international pharmacovigilance guidelines. Being able to discuss these confidently will show that you’re not just familiar with the rules, but that you can apply them strategically in your role.
✨Showcase Your Leadership Experience
Prepare specific examples from your past roles where you’ve successfully led teams or projects. Highlight how you’ve managed compliance and quality assurance, as well as any strategic decisions you made that had a significant impact on the organisation.
✨Demonstrate Your Strategic Thinking
Be ready to discuss how you would approach setting a long-term compliance roadmap. Think about the challenges you might face and how you would overcome them. This will illustrate your ability to think critically and strategically about the role.
✨Engage with the Details
While it’s important to have a big-picture view, don’t forget to show your understanding of the day-to-day operations. Be prepared to talk about how you ensure SOPs are fit for purpose and how you manage CAPA workflows effectively.