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- Tasks: Lead global quality assurance for pharmacovigilance and ensure compliance with regulations.
- Company: Join CSL Seqirus, a leading influenza vaccine provider committed to innovation.
- Benefits: Enjoy competitive benefits, including health support and a culture of inclusion.
- Other info: Dynamic environment with opportunities for continuous improvement and career growth.
- Why this job: Make a real impact in global health while shaping the future of pharmacovigilance.
- 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&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 in Maidenhead employer: CSL Plasma
Contact Detail:
CSL Plasma Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head, PV and Regulatory QA in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like 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. Understand their values and how they align with your own. We want you to walk into that interview room feeling confident and ready to show them why you’re the perfect fit for the Head of PV and Regulatory QA role.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality assurance and regulatory compliance. We suggest doing mock interviews with friends or mentors to refine your answers and get comfortable discussing your experience.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. We believe this shows your enthusiasm for the role and keeps you top of mind for the hiring team.
We think you need these skills to ace Head, PV and Regulatory QA in Maidenhead
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 passionate about pharmacovigilance and how your skills can contribute to our team. Keep it engaging and relevant to the job description.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples that demonstrate your impact in previous roles, especially in areas like audit strategy and regulatory management. We love numbers and results!
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. Let’s get started on this journey together!
How to prepare for a job interview at CSL Plasma
✨Know Your Regulations
Make sure you brush up on GVP, GCP, and ICH guidelines before the interview. Being able to discuss these regulations confidently will show that you have the technical depth needed for the role.
✨Showcase Your Leadership Skills
Prepare examples of how you've led cross-functional teams in the past. Highlight your strategic acumen and operational management experience to demonstrate your ability to influence and drive decisions.
✨Understand the Company’s Vision
Familiarise yourself with CSL Seqirus and its mission. Be ready to discuss how your experience aligns with their goals, especially in terms of continuous improvement and regulatory compliance.
✨Prepare for Scenario Questions
Think about potential scenarios related to audit strategies or inspection management. Prepare to explain how you would handle these situations, showcasing your problem-solving skills and operational rigor.