At a Glance
- Tasks: Lead global quality and compliance for pharmacovigilance systems and ensure regulatory adherence.
- Company: Join Seqirus, a leader in the pharmaceutical industry with a commitment to innovation.
- Benefits: Competitive salary, comprehensive health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for strategic influence and career advancement.
- Why this job: Make a significant impact on global health by ensuring safety and compliance in drug development.
- Qualifications: 10+ years in pharmaceutical QA, strong leadership skills, and deep regulatory knowledge required.
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, PV and Regulatory QA employer: CSL Plasma Inc.
Seqirus UK, located in Maidenhead, is an exceptional employer that prioritises employee growth and development within the dynamic field of pharmacovigilance and regulatory quality assurance. With a strong commitment to strategic governance and operational excellence, employees benefit from a collaborative work culture that encourages innovation and continuous improvement, alongside competitive remuneration and comprehensive benefits. The opportunity to lead global initiatives while working in a supportive environment makes Seqirus an attractive choice for professionals seeking meaningful and rewarding 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 people in the industry, attend events, and connect on LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. We should be ready to discuss how our skills align with their goals. Practise common interview questions and have some thoughtful questions of our own to show we’re genuinely interested.
✨Tip Number 3
Follow up after interviews! A quick thank-you email can go a long way. It shows our enthusiasm for the role and keeps us fresh in their minds. Plus, it’s a great chance to reiterate why we’re the perfect fit.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we often have exclusive roles listed there that you won’t find anywhere else. Let’s get our applications in!
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 is tailored to the Head of PV and Regulatory QA role. Highlight your experience in quality assurance, regulatory compliance, and any leadership roles you've held. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this position. Share specific examples of your strategic leadership and operational excellence in previous roles. We love a good story!
Showcase Your Technical Skills:Don’t forget to highlight your technical mastery in pharmacovigilance processes and regulations. Mention any relevant certifications or training that demonstrate your expertise. We’re looking for someone who knows their stuff!
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, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at CSL Plasma Inc.
✨Know Your Stuff
Make sure you have a solid grasp of pharmacovigilance processes and regulatory guidelines. Brush up on GVP/GCP regulations and be ready to discuss how you've applied them in your previous roles.
✨Showcase Your Leadership Skills
Prepare examples that highlight your leadership experience, especially in managing cross-functional teams. Think about times when you influenced strategic decisions or improved operational processes.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific situations, like managing an inspection or dealing with deviations. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Engage with Their Vision
Research Seqirus and understand their strategic goals. Be prepared to discuss how your vision aligns with theirs and how you can contribute to their long-term compliance roadmap.
