At a Glance
- 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.
- Other info: Collaborative culture with opportunities for professional growth and development.
- 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.
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
Vertex Pharmaceuticals is an exceptional employer that prioritises employee well-being and professional growth. With a flexible hybrid working model, our team enjoys a supportive work culture that fosters collaboration and innovation, while also providing ample opportunities for career advancement in the dynamic field of tax compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Manager, ATC Operational Quality in London
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like Vertex Pharmaceuticals. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Vertex Pharmaceuticals!
We think you need these skills to ace Quality Manager, ATC Operational Quality in London
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Vertex Pharmaceuticals that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Vertex Pharmaceuticals.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Vertex Pharmaceuticals does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Vertex Pharmaceuticals
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Vertex Pharmaceuticals. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Vertex Pharmaceuticals's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Vertex Pharmaceuticals. This shows your passion for the industry!
