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- Tasks: Lead global quality and compliance for pharmacovigilance systems and ensure regulatory adherence.
- Company: Join a leading pharmaceutical company focused on safety and quality in healthcare.
- Benefits: Competitive salary, comprehensive benefits, and opportunities for professional growth.
- Why this job: Make a significant impact on patient safety and regulatory compliance in a dynamic environment.
- Qualifications: 10+ years in Quality Assurance with deep knowledge of GVP/GCP regulations.
- Other info: Collaborative culture with a focus on continuous improvement and strategic leadership.
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&D business and regional affiliates. Your focus is on three core pillars: Strategic Governance, Operational Excellence, and Regulatory Intelligence.
Key Accountabilities:
- Strategic Leadership: Harmonize processes within Global PVRQA and across other GxP areas. Contribute to the larger strategic vision of Global R&D Quality and interact with the Leadership Team to ensure continuous alignment.
- Audit Strategy: Own the long-term, risk-based audit strategy aligned with GVP Module IV; deliver annual internal and external audit programs covering global systems, affiliates, and 3rd party vendors.
- Inspection & Regulatory Management: Lead the preparation, conduct, and response phases for PV health authority inspections and 3rd party audits.
- System Oversight: Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).
- Cross-Functional Expertise: Provide GVP consultancy and cross-GxP expertise (GCP, GDP, GCLP) to ensure coordination across functional areas, including Commercial and Clinical Development.
- Operational Management: Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.
- Resource Stewardship: Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.
- Continuous Improvement: Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.
Your Profile
The successful candidate will be a high-calibre Quality Assurance professional with the executive presence to influence global cross-functional teams and the technical depth to safeguard our Pharmacovigilance system.
Qualifications & Experience:
- Education: Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; 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.
- Communication & Influence: Excellent communication, negotiation, and influencing skills across all levels of the business.
- Operational Rigor: Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans.
Head of Pharmacovigilance and Regulatory Quality Assurance in Maidenhead 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 in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to industry contacts on LinkedIn or at conferences. A personal connection can often get your foot in the door faster than a CV.
✨Tip Number 2
Prepare for interviews by researching the company’s recent projects and challenges. Show them you’re not just another candidate; you’re someone who understands their business and can contribute right away.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with their needs, especially in areas like compliance and quality assurance. Confidence is key!
✨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 genuinely interested in joining us.
We think you need these skills to ace Head of Pharmacovigilance and Regulatory Quality Assurance in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the job description. Highlight your experience in pharmacovigilance and quality assurance, and don’t forget to showcase your leadership skills. We want to see how you’ve made an impact in previous roles!
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. Share specific examples of your strategic leadership and operational excellence.
Showcase Your Regulatory Knowledge: Since this role involves a lot of regulatory compliance, make sure to highlight your understanding of GVP/GCP regulations and any relevant experience with inspections or audits. We love candidates who can demonstrate their expertise in this area!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your materials and ensures you’re considered for the role. Plus, it shows you’re keen on joining the StudySmarter team!
How to prepare for a job interview at CSL
✨Know Your Regulations Inside Out
Make sure you’re well-versed in GVP, GCP, and ICH guidelines. Brush up on the latest regulatory changes and be ready to discuss how they impact pharmacovigilance processes. This shows you’re not just familiar with the rules but also proactive about compliance.
✨Demonstrate Strategic Thinking
Prepare examples of how you've contributed to strategic governance in previous roles. Think about how you’ve harmonised processes or developed audit strategies. Being able to articulate your strategic vision will impress the interviewers and show you can lead at a high level.
✨Showcase Your Leadership Skills
Be ready to discuss your leadership style and how you’ve influenced cross-functional teams. Share specific instances where you’ve managed complex projects or navigated challenging regulatory interactions. This will highlight your ability to lead and inspire others.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like managing inspections or deviation management. Use the STAR method (Situation, Task, Action, Result) to structure your answers. This approach helps you provide clear and concise responses that demonstrate your problem-solving skills.