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: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and collaboration.
- Why this job: Make a real impact in global health by ensuring safety and quality in vaccine production.
- Qualifications: 3 years of GVP or PV quality experience and a relevant scientific degree.
The predicted salary is between 68000 - 108000 £ per year.
Salary: £68,000 - 108,000 per year
Requirements
- 3 years of GVP or PV quality experience, including direct pharmacovigilance vendor or service-provider oversight.
- A track record of owning quality agreements and contributing to a vendor oversight program.
- Working knowledge of audit and inspection management processes.
- Ability 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 preferred.
Responsibilities
- Own the quality oversight of 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.
- Lead the end-to-end PV vendor lifecycle, including qualification and risk-based oversight strategy, quality agreements, CAPA oversight, issue management, and continuous improvement.
- Ensure adherence to GVP, data integrity, and applicable PV regulations across the external PV network.
- Serve as the senior quality point of contact for PV vendor matters and partner with relevant stakeholders.
- Define and own the risk-based qualification and requalification strategy for PV vendors.
- Own the negotiation and maintenance of Quality Agreements.
- Establish vendor KPIs, SLAs, dashboards, and governance forums.
- Lead periodic vendor 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.
- Provide input to deviation, complaint, change control, and CAPA processes.
- Lead risk assessments and set controls and monitoring frequency based on risk.
- Analyze 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.
Technologies
Support Network
We are CSL Seqirus, part of CSL and one of the largest influenza vaccine providers in the world, contributing to the prevention of influenza globally and supporting pandemic preparedness. We operate state-of-the-art production facilities in the U.S., the U.K., and Australia, and we use egg, cell, and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries. We offer benefits support through CSL and foster inclusion and belonging as core parts of our mission and culture. We are an equal opportunity employer and value curiosity, empathy, and a diverse workforce that helps move our company and industry forward.
GVP Vendor Oversight and QA Lead employer: Clever CV
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises innovation and collaboration in the field of pharmacovigilance. With a strong commitment to employee growth, we provide comprehensive training and development opportunities, alongside competitive benefits that support work-life balance. Our inclusive culture fosters diversity and encourages curiosity, making it a rewarding place for professionals looking to make a meaningful impact in global health.
StudySmarter Expert Advice🤫
We think this is how you could land GVP Vendor Oversight and QA Lead
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Clever CV. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Clever CV.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Clever CV. 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 Clever CV 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
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 Clever CV!
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 Clever CV 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 Clever CV!
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 Clever CV, 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 Clever CV
✨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 Clever CV 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 Clever CV’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.
