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- Tasks: Lead QA activities in pharmacovigilance and ensure compliance across global operations.
- Company: Join a globally established pharmaceutical organisation with a focus on innovation.
- Benefits: Competitive salary, professional development, and opportunities for cross-functional collaboration.
- Why this job: Make a real impact on patient safety and regulatory readiness in a dynamic environment.
- Qualifications: Scientific degree and significant QA experience in pharmaceuticals or medical devices.
- Other info: Strong career growth potential and the chance to work with senior stakeholders.
The predicted salary is between 60000 - 80000 £ per year.
AssureBio is supporting a globally established pharmaceutical organisation in the appointment of a GVP QA Manager to strengthen its R&D Quality Assurance function. This is a high-impact role focused on pharmacovigilance quality oversight, vendor governance and regulatory inspection readiness within a global environment. You will operate as a key Quality Subject Matter Expert, ensuring robust compliance, patient safety and proactive regulatory readiness across pharmacovigilance and wider GxP activities. The position offers strong cross-functional exposure, working closely with senior stakeholders, global partners and regulatory bodies.
Key Responsibilities
- GVP & R&D Quality Oversight
- Provide leadership across pharmacovigilance QA activities within R&D and Scientific functions
- Act as SME for GVP/GxP compliance and provide expert regulatory interpretation
- Maintain oversight of Pharmacovigilance System Master File (PSMF) integrity
- Support quality due diligence for new product opportunities
- Audit & Vendor Management
- Develop and maintain the R&D audit schedule
- Lead internal, vendor and third-party audits (acting as Lead or Co-Auditor)
- Oversee quality performance of PV vendors and service providers
- Ensure effective audit closure and CAPA tracking
- Inspection Readiness & Compliance
- Support regulatory inspection preparation and hosting (MHRA, EMA, FDA and global authorities)
- Lead CAPA management arising from inspections and audits
- Provide risk-based QA advice to cross-functional teams
- Review and approve deviations, change controls and quality events
- Quality Systems & Continuous Improvement
- Generate and present R&D quality metrics to senior stakeholders
- Deliver GxP training and guidance across the organisation
- Maintain awareness of evolving regulatory expectations and ensure business readiness
- Support continuous improvement of quality systems and processes
This role is central to ensuring high standards of pharmacovigilance compliance, vendor oversight and inspection readiness across a complex global environment.
Experience & Qualifications
Essential
- Scientific degree (Pharmacy, Chemistry, Biology, Engineering or related) or equivalent experience
- Significant QA experience within pharmaceutical and/or medical device environments
- Strong expertise in Good Pharmacovigilance Practice (GVP)
- Proven experience supporting regulatory inspections and PV teams
- Experience in auditing, CAPA management and quality systems oversight
- Ability to operate autonomously and make risk-based quality decisions
Desirable
- Certification in auditing or Quality Systems Management
- Working knowledge of Good Clinical Practice (GCP)
- Experience managing PV vendors and service providers
- Strong stakeholder engagement and influencing skills
Candidates must demonstrate the ability to operate independently, provide strategic quality input and maintain strong regulatory compliance across global PV operations.
QA Supervisor employer: AssureBio
Contact Detail:
AssureBio Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Supervisor
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those involved in QA. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your GVP knowledge and recent regulatory changes. We want you to be the go-to person for quality assurance discussions, so show off your expertise and confidence!
✨Tip Number 3
Don’t just wait for job alerts; actively engage with companies you admire. Follow them on social media, comment on their posts, and attend their webinars. This way, you’ll be on their radar when opportunities arise.
✨Tip Number 4
Apply through our website for a smoother process! We’ve got your back with resources and tips to help you shine during the application process. Let’s get you that QA Supervisor role!
We think you need these skills to ace QA Supervisor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Supervisor role. Highlight your experience in pharmacovigilance and quality assurance, and don’t forget to mention any relevant certifications or audits you've led. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance and how your skills can contribute to our team. Be sure to mention specific experiences that relate to the responsibilities listed in the job description.
Showcase Your Expertise: As a key Quality Subject Matter Expert, we want to see your knowledge in action. Include examples of how you've ensured compliance and patient safety in previous roles. This will help us understand your approach to quality oversight and regulatory readiness.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of it. Plus, you’ll get to see more about what we do at StudySmarter!
How to prepare for a job interview at AssureBio
✨Know Your Stuff
Make sure you brush up on Good Pharmacovigilance Practice (GVP) and any relevant regulations. Being able to discuss these topics confidently will show that you're not just familiar with the basics, but that you truly understand the complexities of QA in a pharmaceutical setting.
✨Showcase Your Leadership Skills
As a QA Supervisor, you'll need to demonstrate your ability to lead and influence teams. Prepare examples from your past experiences where you've successfully managed audits or led cross-functional teams. This will help illustrate your capability to take charge in high-pressure situations.
✨Prepare for Scenario Questions
Expect questions that put you in hypothetical situations related to compliance and inspection readiness. Think about how you would handle specific challenges, such as managing CAPA processes or dealing with regulatory bodies. Practising these scenarios can help you articulate your thought process clearly.
✨Engage with Your Interviewers
Don't forget that interviews are a two-way street! Prepare thoughtful questions about the company's approach to quality assurance and how they handle vendor management. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.