At a Glance
- Tasks: Oversee quality of external partners in nonclinical research and ensure compliance with regulations.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Enjoy competitive benefits, including health support and a culture of inclusion.
- Other info: Dynamic role with opportunities for growth in a collaborative environment.
- Why this job: Make a real impact on patient safety through quality oversight in research.
- Qualifications: Bachelor's degree and 3+ years of GxP quality experience required.
The predicted salary is between 60000 - 75000 £ 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 Maidenhead employer: CSL Plasma
CSL Seqirus is an exceptional employer that prioritises employee well-being and professional growth, offering a collaborative work culture where inclusion and belonging are at the forefront. With opportunities to lead critical vendor oversight in a global context, employees can make a meaningful impact on public health while benefiting from comprehensive support and development resources. Located in a dynamic environment, CSL Seqirus fosters innovation and encourages a diverse workforce, making it an attractive place for those seeking rewarding careers in the life sciences sector.
StudySmarter Expert Advice🤫
We think this is how you could land GLP/GCLP Vendor Oversight and QA Lead (EU) in Maidenhead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL Plasma. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like CSL Plasma.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like CSL Plasma. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what CSL Plasma is looking for. A tailored application can really make you stand out!
We think you need these skills to ace GLP/GCLP Vendor Oversight and QA Lead (EU) in Maidenhead
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at CSL Plasma!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show CSL Plasma that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at CSL Plasma!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At CSL Plasma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at CSL Plasma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at CSL Plasma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with CSL Plasma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
