At a Glance
- Tasks: Lead global quality and compliance for pharmacovigilance systems and ensure regulatory adherence.
- Company: Join a leading pharmaceutical company focused on safety and compliance.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Other info: Collaborate with global teams and drive strategic initiatives in pharmacovigilance.
- Why this job: Make a significant impact on patient safety and regulatory excellence in a dynamic environment.
- Qualifications: 10+ years in pharmaceutical QA 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.
Inspection: an advanced degree is preferred.
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.
Head, PV and Regulatory QA employer: CSL
As an Associate Director in Procurement Enablement at CSL, you will be part of a forward-thinking organisation that prioritises sustainability and governance while fostering a culture of continuous improvement and talent development. With a commitment to employee growth through the Global Procurement Academy and a collaborative work environment, CSL offers a unique opportunity to influence procurement practices on a global scale, making it an excellent employer for those seeking meaningful and impactful careers.
StudySmarter Expert Advice🤫
We think this is how you could land Head, PV and Regulatory QA
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at events. We all know that sometimes it’s not just what you know, but who you know that can get you in the door.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We want you to show them you’re not just a fit for the role, but for the team too. Tailor your answers to reflect their values and mission.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or mentors. We can’t stress enough how important it is to articulate your experience and skills confidently.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way. It shows your enthusiasm for the role and keeps you fresh in their minds. And remember, apply through our website for the best chance!
We think you need these skills to ace Head, PV and Regulatory QA
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the specific skills and experiences that align with the Head of PV and Regulatory QA role. Highlight your leadership experience and knowledge of GVP/GCP regulations to show us you’re the right fit.
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 strategic acumen can benefit our team. Be sure to mention any relevant achievements that demonstrate your expertise.
Showcase Your Leadership Skills:We want to see your leadership track record! Include examples of how you've successfully managed teams or projects in the past, especially in relation to quality assurance and compliance within the pharmaceutical industry.
Apply Through Our Website:Don’t forget to apply through our website! 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 the StudySmarter family!
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 of how you've led teams or projects in Quality Assurance. Highlight your strategic acumen and how you've managed complex regulatory interactions. This will demonstrate your capability to bridge oversight with operational leadership.
✨Understand the Bigger Picture
Be ready to discuss how you would set a long-term compliance roadmap while managing day-to-day quality assurance. Think about how you can align your vision with the company’s goals and be prepared to share your thoughts on evolving the PVRQA function.
✨Engage with the Details
Don’t shy away from discussing the nitty-gritty of SOPs, CAPA workflows, and inspection readiness. Showing that you can dive into the details while keeping an eye on the strategic direction will impress interviewers looking for a hands-on leader.
