Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- 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 for GMP operations and strong problem-solving skills.
The predicted salary is between 60000 - 75000 £ per year.
Quality Assurance Operational Manager, 12-month contract
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 Quality Assurance Operational Manager will provide QA support for manufacturing operations for the manufacture of Cell & Genetic Therapeutic programs.
- Review & support 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.
- Provide QA support for change controls, process and OOS investigations, and associated CAPAs related to batch records and manufacturing.
- Provide manufacturing support and guidance for GMP product quality impact assessments.
- Responsible for identifying compliance risks and gaps for GMP batch record processes.
- Support audit and inspection readiness activities.
- Act as a trusted advisor by providing compliance guidance through collaborative review and partnering with business stakeholders and contract manufacturers.
- Support the vendor management process, including the creation and review of Quality Agreements with suppliers.
- Assist with addressing product complaints.
- Maintain monthly/quarterly batch record metrics and assist department with routine/quarterly Quality System data review metrics and reporting.
- Lead and participate in Cell & Genetic Program and Quality projects and drive continuous improvement activities.
Demonstrated experience providing QA support to GMP manufacturing operation. Experience successfully leading event investigations, Root Cause Analysis and CAPA. Experience with network-based applications such as Oracle, TrackWise, Veeva. Understanding of regulatory environment including quality systems and compliance. Knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing. Professional membership or equivalent in relevant societies, network of knowledge in cell and gene therapy industry. Ability to evaluate quality matters and make decisions utilizing risk-based approach. Ability to independently lead cross-functional teams and effectively communicate with business stakeholders.
Quality Assurance Manager - Operations employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager - Operations
✨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 lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and quality assurance principles. We recommend practising common interview questions related to compliance and risk management to show you're the right fit for the role.
✨Tip Number 3
Showcase your experience with relevant software like Oracle and TrackWise during interviews. We want to see how you can leverage these tools to enhance quality assurance processes at Vertex.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who can contribute to our mission in the biotech field.
We think you need these skills to ace Quality Assurance Manager - Operations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Manager role. Highlight your experience in GMP manufacturing and any relevant projects you've led. 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 the perfect fit for this role. Mention specific experiences that relate to quality assurance and compliance, and show us your passion for the biotechnology field.
Showcase Your Technical Skills: Don’t forget to mention your experience with network-based applications like Oracle or Veeva. If you’ve got knowledge in cell technology or aseptic manufacturing, make sure that stands out. We love seeing those technical skills in action!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. Good luck!
How to prepare for a job interview at Vertex Pharmaceuticals
✨Know Your Quality Assurance Inside Out
Make sure you brush up on your knowledge of quality assurance principles and compliance, especially as they relate to GMP manufacturing. Be ready to discuss specific examples from your past experience that demonstrate your expertise in batch record reviews, deviations, and CAPA processes.
✨Familiarise Yourself with the Company
Research Vertex Pharmaceuticals and their focus on cell and gene therapies. Understanding their pipeline and recent innovations will not only impress your interviewers but also help you tailor your responses to align with their mission and values.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to solve hypothetical problems related to quality assurance. Prepare by thinking through potential compliance risks or gaps you’ve encountered in previous roles and how you addressed them. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Showcase Your Collaborative Skills
As a Quality Assurance Operational Manager, you'll need to work closely with various stakeholders. Be prepared to share examples of how you've successfully led cross-functional teams or collaborated with contract manufacturers to achieve quality objectives. Highlight your communication skills and ability to act as a trusted advisor.