At a Glance
- Tasks: Oversee quality of external partners in nonclinical and GLP activities, ensuring data integrity.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider committed to innovation.
- Benefits: Enjoy competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic role with cross-functional collaboration and excellent career advancement opportunities.
- Why this job: Make a real impact on patient safety by ensuring high-quality research standards.
- Qualifications: Bachelor's degree and 3+ years of GxP quality experience required.
The predicted salary is between 60000 - 80000 £ per year.
The integrity of nonclinical data depends on more than what happens inside a company's walls. Much of the critical work in GLP-regulated research — safety studies, toxicology, analytical testing — is carried out by external laboratories and CROs. When that network of partners operates to the highest quality standards, the science is sound. When it doesn't, the consequences reach all the way to patients. This role exists to make sure it works.
Why this role matters
GLP vendor oversight is often invisible when it's done well — and very visible when it isn't. As the internal authority on GLP and nonclinical vendor quality, you will be the person others turn to when the questions are difficult. If you take data integrity seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external nonclinical network, this is a role with real scope to make a difference.
About the role
- Own quality oversight of external partners supporting nonclinical and GLP activities (CROs, laboratories, test facilities).
- Lead the vendor lifecycle: due diligence, qualification, quality agreements, risk-based monitoring, issue management and continuous improvement, ensuring adherence to GLP/GCP/GMP, data integrity and applicable regulations.
- Partner with Nonclinical Development, Procurement, Legal and IT.
- Vendor Lifecycle and Governance: Run risk-based qualification and requalification, draft and maintain Quality Agreements, and set vendor KPIs and governance forums, ensuring actions and CAPAs are closed.
- Inspections: Identify and prioritise vendors for audit on a risk basis; planning, conducting and grading sits with the audit function. Confirm vendor CAPAs are fit for purpose and run effectiveness checks. Coordinate inspection readiness and front- and back-room support.
- Quality Systems and Compliance: Ensure vendor practices meet GLP/GCP/GMP, OECD GLP, 21 CFR Part 58, ICH, ISO and data integrity (ALCOA+). Provide input on third-party deviations, change control, CAPA, and the QMS.
- Risk Management and Continuous Improvement: Lead vendor risk assessments (risk registers, FMEA) to set oversight frequency, improve vendor performance, and present trends at management reviews.
- Cross-Functional Partnership: Embed quality requirements in scopes of work and contracts, guide technology transfers and data flows, and train internal stakeholders.
- Maintain and share knowledge of Regulations and Requirements: Stay current with GLP and GxP regulations and translate changes into CSL requirements.
Position Qualifications and Experience Requirements:
- Education: Bachelor's degree in a relevant scientific discipline.
- Experience: 3+ years of GxP quality experience with direct vendor/CRO oversight and/or auditing (GLP/GCP/GMP), nonclinical/GLP preferred. Knowledge of OECD GLP, 21 CFR Part 58, Annex 11/Part 11 and data integrity (ALCOA+). Strong communication and negotiation skills.
- Competencies: Works with limited supervision across multinational teams. Strong analytical, problem-solving, influencing and organisational skills. Knowledge of QMS implementation, regulatory frameworks and audit/inspection management.
GLP/GCLP Vendor Oversight and QA Lead (EU) in London employer: CSL Seqirus
CSL Seqirus is an exceptional employer that prioritises inclusion and belonging, fostering a culture of curiosity and empathy. With a commitment to employee growth and development, the company offers robust benefits and opportunities for advancement within a global network dedicated to improving public health through innovative vaccine solutions. Working in this role not only allows you to make a significant impact on data integrity and quality oversight but also positions you within a supportive environment that values diverse perspectives and collaboration.
StudySmarter Expert Advice🤫
We think this is how you could land GLP/GCLP Vendor Oversight and QA Lead (EU) in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. This will help you answer questions more authentically and show that you're genuinely interested in the role.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms. This will help you get comfortable with common questions and refine your responses, making you feel more confident when it’s time for the real deal.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can go a long way in leaving a positive impression. Plus, it shows your enthusiasm for the position and keeps you on their radar.
We think you need these skills to ace GLP/GCLP Vendor Oversight and QA Lead (EU) in London
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in GLP and vendor oversight. We want to see how your skills align with the role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Knowledge:Demonstrate your understanding of GLP/GCP/GMP regulations and data integrity principles. We’re looking for someone who can navigate the regulatory landscape, so include specific examples of how you've applied this knowledge in your previous roles.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key points stand out. This will help us quickly see why you’re a great fit for the team!
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at CSL Seqirus
✨Know Your GLP Inside Out
Make sure you brush up on your knowledge of GLP, GCP, and GMP regulations. Be prepared to discuss how these standards apply to vendor oversight and quality assurance. This will show that you’re not just familiar with the terms but can also apply them in real-world scenarios.
✨Showcase Your Analytical Skills
Prepare examples that highlight your analytical and problem-solving skills. Think about past experiences where you identified risks or improved vendor performance. Being able to articulate these situations will demonstrate your capability to lead risk assessments and continuous improvement initiatives.
✨Communicate Effectively
Strong communication is key in this role. Practice explaining complex concepts in simple terms, as you’ll need to partner with various teams. Consider role-playing with a friend to refine your ability to convey information clearly and confidently.
✨Be Ready for Scenario Questions
Expect scenario-based questions that test your decision-making and prioritisation skills. Prepare by thinking through potential challenges you might face in vendor oversight and how you would handle them. This will help you demonstrate your readiness for the role and your proactive approach to problem-solving.
