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- Tasks: Lead quality management for apheresis services, ensuring compliance and patient safety.
- Company: Join a leading pharmaceutical and cellular therapy organisation in London.
- Benefits: Competitive salary, professional development, and a chance to make a real impact.
- Other info: Opportunity to lead cross-functional teams in a dynamic environment.
- Why this job: Be at the forefront of quality in innovative healthcare solutions.
- Qualifications: Experience in cellular therapy or HTA regulated environments is preferred.
The predicted salary is between 50000 - 65000 £ 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.
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.
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.
Quality Coordinator Inspections employer: Blackfield Associates
Contact Detail:
Blackfield Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Coordinator Inspections
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and cellular therapy sectors on LinkedIn. Join relevant groups and engage in discussions to get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of quality management systems and regulatory compliance. Be ready to discuss how your experience aligns with the role of Quality Coordinator Inspections.
✨Tip Number 3
Showcase your skills through real-life examples. When you get the chance to interview, share specific instances where you've led quality initiatives or improved processes in previous roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed and shows your commitment to joining our team.
We think you need these skills to ace Quality Coordinator Inspections
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Coordinator Inspections role. Highlight your experience in quality management systems, regulatory compliance, and any relevant work in cellular therapy or apheresis. We want to see how your background aligns with what we're looking for!
Showcase Your Skills: Don’t just list your responsibilities; showcase your achievements! Use specific examples that demonstrate your ability to lead cross-functional teams and manage quality governance. We love seeing how you’ve made an impact in previous roles.
Be Clear and Concise: Keep your application clear and to the point. Use bullet points where possible and avoid jargon unless it’s relevant to the role. We appreciate straightforward communication that gets right to the heart of your qualifications.
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It helps us keep track of applications and ensures you’re considered for this exciting opportunity. Don’t miss out!
How to prepare for a job interview at Blackfield Associates
✨Know Your Quality Management Systems
Familiarise yourself with the key components of Quality Management Systems (QMS) relevant to apheresis and cellular therapy. Be ready to discuss your experience with document control, change control, and CAPA processes, as these will likely be focal points during the interview.
✨Demonstrate Regulatory Knowledge
Brush up on HTA licensing and CQC standards. Prepare to explain how you've ensured compliance in previous roles, and think of examples where you’ve successfully navigated inspections or audits. This shows you’re not just familiar with regulations but can actively manage them.
✨Showcase Your Leadership Skills
Since this role involves leading cross-functional teams, be prepared to share specific instances where you’ve led projects or initiatives. Highlight your ability to work independently while also fostering collaboration among team members to achieve quality goals.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past challenges you faced in quality governance or patient safety, and how you approached them. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.