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- Tasks: Support quality operations for gene therapy treatment centres and ensure compliance with regulatory standards.
- Company: Vertex Pharmaceuticals, a leading global biotechnology company focused on innovative medicines.
- Benefits: 12-month contract, competitive pay, and the chance to make a real difference in patients' lives.
- Why this job: Join a mission-driven team and contribute to life-saving therapies in a dynamic environment.
- Qualifications: Experience in quality assurance, particularly in apheresis or cell therapy, is essential.
- Other info: Collaborative culture with opportunities for professional growth and development.
The predicted salary is between 48000 - 84000 £ per year.
Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 12 months
Location: London, Paddington
Department: Quality Assurance
Looking for opportunities with purpose, impact and possibilities? Our client, Vertex, is a global biotechnology company that invests in scientific innovation. As they grow their pipeline at pace, they are strengthening their reputation for creating transformative medicines for people with serious diseases.
General Summary:
The Apheresis Quality Operations Manager will support the activation of commercial gene therapy Authorized Treatment Centers. The role will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers. This role will be supporting the activation of the Authorized Treatment Centers (commercial sites) and will work closely with the Apheresis and Infusion Operations team and the QA Audit team in qualifying sites partnering to provide life-saving cell and gene therapy to patients in need.
The Quality Manager will complete the execution of the quality Risk Management Plans that will govern the monitoring and oversight by QA and business functions, working closely with the business stakeholders and the functions within the Quality organization with the objective of ensuring transparency for gaining insights regarding operational risks and mitigations. This individual is expected to demonstrate success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality.
The Quality Manager is responsible to support real-time treatment center assessment activities within VCGT Quality. The Quality Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment.
Key Duties and Responsibilities:
- Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight to evaluate treatment centers ensuring compliance with standards established by applicable regulatory, licensing, and accrediting bodies.
- Conduct treatment center Audits where required.
- Actively engage with the Audit Management, Vendor Management and Apheresis Infusion Operations functions on site qualifications.
- Establish and maintain Quality Agreements.
- Work with the business areas on site selection.
- Provide QA support of change controls, investigations, CAPA's and effectiveness checks.
- Responsible for identifying risks and communicating gaps for process/systems.
- Coordinate preparation activities with SMEs.
- Real-time Inspection Readiness.
- Develop, utilize, and continue to mature tools to ensure efficiency in execution.
- Support initiatives associated with maintaining relevant inspection related history for inspection readiness purposes.
- Identify areas of improvement and participate in process improvement initiatives.
- Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement.
- Additional activities as needed to support the Quality Systems.
- Author/Revise Standard Operating Procedures and associated forms.
Knowledge and Skills:
- Strong apheresis and/or cellular therapy Quality or Operations background.
- Project Management Skills.
- Operational QA experience with experience with the following is preferred: Inspection support roles, Quality System background, Understanding of GMP/GDPs/GTP and applicable guidelines/guidance.
- Ability to collaborate with cross-functional teams.
- Excellent technical writing, presentation, and communication skills.
- Experience conducting investigations, performing Root Cause Analysis, and identifying CAPA.
Education and Experience:
- Bachelor's / Masters degree required.
- Background in Quality Assurance supporting apheresis, transplant, or cell-therapy lab in a biotech/pharma or healthcare setting.
Seniority level: Not Applicable
Employment type: Contract
Job function: Quality Assurance
Industries: Biotechnology Research and Pharmaceutical Manufacturing
Quality Manager, ATC Operational Quality in London employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Manager, ATC Operational Quality in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharma sectors. A friendly chat can lead to insider info about job openings or even a referral. Don’t be shy; we all love a good natter!
✨Tip Number 2
Prepare for interviews by researching Vertex Pharmaceuticals and their quality assurance practices. Show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute. We want to see that passion!
✨Tip Number 3
Practice your STAR technique for answering behavioural questions. Structure your responses around Situation, Task, Action, and Result. This will help you articulate your experience clearly and effectively, making it easier for interviewers to see your fit.
✨Tip Number 4
Don’t forget to follow up after your interview! A quick thank-you email can leave a lasting impression. It shows you’re keen and professional, which is exactly what we want to see in a Quality Manager.
We think you need these skills to ace Quality Manager, ATC Operational Quality 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 assurance, especially in apheresis or cellular therapy. We want to see how your skills align with the job description!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality management and how you can contribute to Vertex's mission. Keep it concise but impactful – we love a good story!
Showcase Your Technical Skills: Don’t forget to mention your technical writing and project management skills. These are crucial for the role, so give us examples of how you've used them in past positions. We want to see your expertise in action!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any updates. Let’s get you on board!
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your Quality Standards
Make sure you’re well-versed in the relevant quality standards and regulations, especially those related to apheresis and cell therapy. Brush up on GMP, GDP, and GTP guidelines, as these will likely come up during your interview.
✨Showcase Your Collaboration Skills
Since this role involves working closely with various teams, be prepared to discuss examples of how you've successfully collaborated in the past. Highlight any experiences where you engaged stakeholders to improve quality outcomes or operational excellence.
✨Prepare for Technical Questions
Expect technical questions related to quality risk assessments and audit strategies. Review your past experiences with conducting audits and managing quality agreements, and be ready to explain your thought process and methodologies.
✨Demonstrate Continuous Improvement Mindset
Vertex Pharmaceuticals values continuous quality improvement. Be ready to share specific examples of how you've identified areas for improvement in previous roles and the steps you took to implement changes effectively.