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- Tasks: Lead quality assurance for innovative biotech manufacturing and ensure compliance with industry standards.
- Company: Vertex Pharmaceuticals, a leader in transformative medicines for serious diseases.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career advancement.
- Why this job: Join a pioneering team making a real difference in healthcare through cutting-edge therapies.
- Qualifications: Experience in QA support for GMP operations and strong problem-solving skills.
The predicted salary is between 50000 - 65000 £ per year.
Quality Assurance Operational Manager, 12-month contract at Vertex Pharmaceuticals.
Type of Role: Contract position, Inside IR35
Location: Hybrid, 3 days on site in Paddington, London.
Department: Operational Area Quality
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.
The Quality Assurance Operational Manager is recognized as an expert internally in the principles and application of quality assurance and compliance. The role includes:
- Providing QA support for manufacturing operations for the manufacture of Cell & Genetic Therapeutic programs.
- Reviewing & supporting activities related to product disposition including review of batch data, batch records, deviations, in-process data, EM data, QC release testing and other quality systems documentation.
- Responsible for GMP batch disposition activities including review and approval of batch records, deviations, in-process data, EM data, QC release testing, materials review board and other quality activities as applicable to determine acceptability of product disposition.
- Providing QA support for change controls, process and OOS investigations, and associated CAPAs related to batch records and manufacturing.
- Providing manufacturing support and guidance for GMP product quality impact assessments.
- Identifying compliance risks and gaps for GMP batch record processes.
- Supporting audit and inspection readiness activities.
- Acting as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
- Supporting the vendor management process, including the creation and review of Quality Agreements with suppliers.
- Assisting with addressing product complaints.
- Maintaining monthly/quarterly batch record metrics and assisting department with routine/quarterly Quality System data review metrics and reporting.
- Leading and participating in Cell & Genetic Program and Quality projects and driving continuous improvement activities.
Demonstrated experience providing QA support to GMP manufacturing operation is required. Experience successfully leading event investigations, Root Cause Analysis and CAPA is essential. Familiarity with network-based applications such as Oracle, TrackWise, Veeva is preferred. Understanding of regulatory environment including quality systems and compliance is necessary. Knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing is beneficial. Professional membership or equivalent in relevant societies, along with a network of knowledge in the cell and gene therapy industry is advantageous. The ability to evaluate quality matters and make decisions utilizing a risk-based approach is crucial. The candidate should be able to independently lead cross-functional teams and effectively communicate with business stakeholders.
Quality Assurance and Operations Supervisor employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance and Operations Supervisor
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those connected to Vertex or similar companies. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and quality assurance principles. Be ready to discuss how your experience aligns with the role's requirements—show them you’re the perfect fit!
✨Tip Number 3
Don’t forget to showcase your problem-solving skills! Be prepared to share examples of how you've tackled compliance issues or led investigations in the past. This will demonstrate your expertise and readiness for the role.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Quality Assurance and Operations Supervisor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance and Operations Supervisor role. Highlight your relevant experience in QA support, GMP manufacturing, and any specific technologies mentioned in the job description. We want to see how your skills align with what Vertex is looking for!
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 background makes you a perfect fit for this role. Don’t forget to mention your understanding of regulatory environments and compliance – it’s key for this position!
Showcase Your Achievements: When detailing your experience, focus on your achievements rather than just responsibilities. Did you lead a successful CAPA or improve a process? Share those stories! We love seeing how you've made an impact in previous roles.
Apply Through Our Website: We encourage you to apply through our website for the best chance of success. It streamlines the process and ensures your application gets to the right people at Vertex. Plus, it shows you’re serious about joining the team!
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your Quality Assurance Basics
Make sure you brush up on the key principles of quality assurance and compliance. Vertex is looking for someone who can demonstrate a solid understanding of GMP batch disposition activities, so be ready to discuss your experience with batch records and deviations.
✨Showcase Your Problem-Solving Skills
Prepare to share specific examples of how you've successfully led event investigations or conducted Root Cause Analysis in the past. Vertex values candidates who can think critically and make decisions using a risk-based approach, so highlight your analytical skills.
✨Familiarise Yourself with Relevant Technologies
Since the role involves working with network-based applications like Oracle and TrackWise, it’s a good idea to familiarise yourself with these systems. If you have experience with them, be sure to mention it during the interview to show you’re ready to hit the ground running.
✨Prepare Questions for Your Interviewers
Think about insightful questions you can ask about Vertex's approach to quality assurance and their ongoing projects in cell and gene therapy. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.