At a Glance
- Tasks: Lead quality oversight for pharmacovigilance vendors and ensure compliance with regulations.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive benefits, including health support and a focus on well-being.
- Other info: Be part of an inclusive culture that values diversity and innovation.
- Why this job: Make a real impact in patient safety and contribute to global health.
- Qualifications: 3+ years in GVP or PV quality, strong communication skills, and a relevant degree.
The predicted salary is between 60000 - 80000 £ per year.
This role owns the quality oversight of CSL's pharmacovigilance vendors and service providers, including safety and PV CROs, ICSR and case processing providers, literature monitoring, signal management, medical information and call centre providers. You will lead the end-to-end PV vendor lifecycle: defining qualification and risk-based oversight strategy, owning quality agreements, overseeing CAPAs, and driving issue management and continuous improvement, ensuring adherence to GVP, data integrity and applicable PV regulations. You will be the senior quality point of contact for PV vendor matters, partnering with and influencing relevant stakeholders.
What you will do
- Define and own the risk-based qualification and requalification strategy for PV vendors, and own the negotiation and maintenance of Quality Agreements.
- Establish vendor KPIs, SLAs, dashboards and governance forums, and lead periodic reviews to hold vendors accountable and ensure CAPAs are implemented, verified and effective.
- Lead PV inspection readiness for vendor-related scope, including front and back room support and storyboard development.
- Set the quality standards expected of PV vendors against GVP, ICH, GVP Modules and ALCOA+; own the QMS procedures, templates and training governing PV vendor oversight; and provide input to deviation, complaint, change control and CAPA processes.
- Lead risk assessments, set controls and monitoring frequency based on risk, and analyse trends across audit findings, deviations and complaints to inform management reviews.
- Maintain expert knowledge of GVP regulations and PV industry trends, and act as the internal reference point.
What you will bring
- 3+ years of GVP or PV quality experience, including direct pharmacovigilance vendor or service-provider oversight.
- Track record of owning quality agreements and contributing to a vendor oversight programme.
- Working knowledge of audit and inspection management processes. You will not conduct audits, but you will need to assess audit findings, review CAPA adequacy and own effectiveness checks.
- Demonstrated knowledge of GVP Modules, EU pharmacovigilance legislation, ICH guidance and ALCOA+ data integrity principles.
- Strong communication, influencing and negotiation skills at stakeholder and vendor level.
- Ability to work autonomously.
- Bachelor's degree in a relevant scientific discipline; postgraduate qualification desirable.
GVP Vendor Oversight and QA Lead (EU) employer: CSL Seqirus
CSL Seqirus is an exceptional employer that prioritises employee well-being and fosters a culture of inclusion and belonging. With a commitment to innovation and professional growth, employees benefit from comprehensive support systems, opportunities for career advancement, and the chance to contribute to global health initiatives in a dynamic and collaborative environment.
StudySmarter Expert Advice🤫
We think this is how you could land GVP Vendor Oversight and QA Lead (EU)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at CSL or similar companies. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into GVP regulations and the latest trends in pharmacovigilance. Show us you know your stuff and can talk confidently about how you’d handle vendor oversight and quality agreements.
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. Sometimes, the best opportunities come from being proactive and showing your enthusiasm for the role.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that shows your appreciation and keeps you fresh in their minds. Plus, it’s a great chance to reiterate your interest in the role!
We think you need these skills to ace GVP Vendor Oversight and QA Lead (EU)
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in GVP and PV vendor oversight. We want to see how your skills align with the specific requirements of the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Knowledge:Demonstrate your understanding of GVP regulations and pharmacovigilance trends in your application. We’re looking for someone who can not only follow guidelines but also contribute to continuous improvement, so let us know how you’ve done this in the past.
Be Clear and Concise:When writing your application, keep it clear and to the point. We appreciate well-structured responses that get straight to the heart of your experience and qualifications. Avoid jargon unless it’s relevant to the role!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details you need about the position there!
How to prepare for a job interview at CSL Seqirus
✨Know Your GVP Inside Out
Make sure you brush up on your knowledge of GVP regulations and pharmacovigilance principles. Being able to discuss these confidently will show that you're not just familiar with the terms, but that you truly understand their implications in vendor oversight.
✨Prepare for Scenario Questions
Expect questions about how you would handle specific situations related to vendor management and quality oversight. Think of examples from your past experience where you've successfully navigated challenges, especially around CAPAs and quality agreements.
✨Showcase Your Communication Skills
Since this role involves influencing stakeholders and negotiating with vendors, be ready to demonstrate your communication prowess. Practice articulating your thoughts clearly and concisely, and think of instances where your communication made a difference in a project.
✨Bring Data to the Table
Familiarise yourself with key performance indicators (KPIs) and service level agreements (SLAs) relevant to vendor oversight. Be prepared to discuss how you’ve used data to drive improvements or hold vendors accountable in previous roles.
