At a Glance
- Tasks: Lead quality management for apheresis services and ensure regulatory compliance.
- Company: Leading pharmaceutical and cellular therapy organisation in London.
- Benefits: Competitive salary, professional development, and a chance to make a real impact.
- Other info: Opportunity for career growth in a dynamic and innovative environment.
- Why this job: Join a pioneering team and shape the future of patient safety in cellular therapy.
- Qualifications: Experience in cell therapy, apheresis operations, and quality management systems.
The predicted salary is between 60000 - 80000 € per year.
Blackfield Associates is exclusively partnered with a leading pharmaceutical and cellular therapy organisation in London in the search for a Quality Manager - Apheresis. This is a key quality leadership role within a newly established apheresis service, responsible for leading the Quality Management System, ensuring regulatory compliance and patient safety, and overseeing quality governance, HTA and CQC readiness, the collection environment, and third party oversight.
Other key responsibilities include:
- Leading the QMS for the apheresis unit, including document control, change control, risk management, training, deviations, CAPA, complaints, and management review.
- Ensuring readiness for HTA licensing and CQC standards through gap analysis, action plans, inspection preparation, and audit closeout.
- Acting as the HTA Person Designated for the collection facility, with responsibility for licence governance and reporting to the Designated Individual.
- Overseeing the collection environment, including critical parameters, environmental standards, chain of identity, documentation flow, and handover processes.
- Supporting training, competency, and continuous improvement through quality reporting, KPI review, incident investigation, RCA, and CAPA.
The ideal candidate will have strong knowledge of cell therapy and apheresis operations, incident investigation, RCA, and CAPA. Experience within a cellular therapy or apheresis collection facility, or within an HTA licensed establishment, would be highly desirable, along with the ability to work independently, lead cross functional teams, and bring a practical, detail focused approach to quality and compliance.
If you are an experienced Quality professional with a background in cellular therapy, apheresis, or HTA regulated environments and you are interested in this unique opportunity, please send your up to date CV to Oliver@BlackfieldAssociates.com.
Quality Manager - Apheresis in London employer: LinkedIn
At Blackfield Associates, we pride ourselves on being an exceptional employer, offering a dynamic work environment in the heart of London. Our commitment to employee growth is reflected in our robust training programmes and opportunities for advancement within the rapidly evolving field of cellular therapy. Join us to be part of a collaborative culture that prioritises innovation, patient safety, and regulatory excellence, making a meaningful impact in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager - Apheresis in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical and cellular therapy sectors. We all know that sometimes it’s not just what you know, but who you know that can get you in the door.
✨Tip Number 2
Prepare for interviews by researching the company and its apheresis services. We want you to show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute to quality management.
✨Tip Number 3
Practice your responses to common interview questions, especially those related to quality management systems and regulatory compliance. We suggest using the STAR method to structure your answers – it’ll help you shine!
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can go a long way in showing your enthusiasm for the role. And remember, applying through our website gives you a better chance of being noticed!
We think you need these skills to ace Quality Manager - Apheresis in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Manager role. Highlight your experience in quality management systems, regulatory compliance, and any specific knowledge of apheresis or cellular therapy. We want to see how your background aligns with what we're looking for!
Showcase Relevant Experience:When writing your application, focus on showcasing your relevant experience in HTA licensed establishments or similar environments. Mention specific projects or responsibilities that demonstrate your ability to lead quality initiatives and ensure patient safety.
Be Clear and Concise:Keep your application clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and achievements. We appreciate straightforward communication that gets to the point!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. This way, we can easily track your application and get back to you quicker. Plus, it shows you're keen on joining our team at StudySmarter!
How to prepare for a job interview at LinkedIn
✨Know Your Quality Management Systems
Make sure you brush up on your knowledge of Quality Management Systems, especially in the context of apheresis and cellular therapy. Be ready to discuss how you've implemented or improved QMS in previous roles, as this will show your practical experience and understanding of regulatory compliance.
✨Prepare for Regulatory Questions
Since this role involves ensuring HTA and CQC readiness, expect questions about these regulations. Familiarise yourself with the latest standards and be prepared to discuss how you've navigated compliance challenges in the past. This will demonstrate your expertise and readiness for the role.
✨Showcase Your Leadership Skills
As a Quality Manager, you'll need to lead cross-functional teams. Think of examples where you've successfully led a team through a quality improvement project or managed a crisis. Highlight your ability to motivate others and drive change, as this is crucial for the position.
✨Emphasise Continuous Improvement
Be ready to talk about your approach to continuous improvement and how you've used KPIs, incident investigations, and CAPA processes in your previous roles. Share specific examples that illustrate your detail-focused approach and commitment to enhancing quality and patient safety.
