At a Glance
- Tasks: Oversee quality of pharmacovigilance vendors and ensure compliance with regulations.
- Company: Join CSL Seqirus, a leading global influenza vaccine provider.
- Benefits: Comprehensive benefits package and a culture of inclusion and belonging.
- Other info: Dynamic role with opportunities for professional growth and development.
- Why this job: Make a real impact on patient safety and shape vendor quality standards.
- Qualifications: 3+ years in GVP or PV quality, strong communication skills, and relevant degree.
The predicted salary is between 60000 - 80000 £ per year.
Patient safety depends on more than what happens inside a company's walls. Much of the critical work in pharmacovigilance — case processing, literature monitoring, signal management, medical information — is carried out by external partners. When that network of vendors operates to the highest quality standards, the system works. When it doesn't, the consequences are real. This role exists to make sure it works.
Why this role matters
PV quality oversight is often invisible when it's done well — and very visible when it isn't. As the internal authority on GVP vendor quality, you will be the person others turn to when the questions are difficult. If you take quality seriously, understand the regulatory landscape deeply, and want to shape how a global company manages its external PV network, this is a role with real scope to make a difference.
What you will do
- 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.
- 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.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus.
GVP Vendor Oversight and QA Lead (EU) in Maidenhead employer: CSL Plasma
CSL Seqirus is an exceptional employer that prioritises patient safety and quality in pharmacovigilance, offering a dynamic work environment where your expertise can truly make a difference. With a strong commitment to inclusion and belonging, employees are encouraged to grow and innovate while enjoying comprehensive benefits and a culture that values diversity. Located in a state-of-the-art facility, this role provides the opportunity to lead critical vendor oversight initiatives within a global leader in influenza vaccine production.
StudySmarter Expert Advice🤫
We think this is how you could land GVP 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.
✨Tailor Your Approach
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 GVP 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.
