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- Tasks: Lead quality assurance for innovative biotech manufacturing and ensure compliance with industry standards.
- Company: Vertex Pharmaceuticals, a global leader in transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and innovation.
- Why this job: Join a mission-driven team making a real difference in patients' lives.
- Qualifications: Experience in QA for GMP manufacturing and strong problem-solving skills.
The predicted salary is between 60000 - 75000 £ per year.
Quality Assurance Operational Manager, 12-month contract
Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Location: Hybrid, 3 days on site in Paddington, London.
Department: Operational Area Quality
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.
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.
This role will drive; 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.
Key Duties and Responsibilities:- 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.
- Responsible for approval of COAs and product labelling.
- Provide manufacturing support and guidance for GMP product quality impact assessments.
- Review and approval of manufacturing documents.
- Support GMP release of incoming raw material and components.
- 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 assists 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.
- Must have experience with batch record review and batch release.
- 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.
- Critical Thinking and Problem-Solving skills.
Vertex is partnering with Talent Works to manage their international temporary job openings. If you are successful in your application, you will be employed by Talent Works to work on a temporary assignment at Vertex.
Quality Assurance Operations Manager in Plymouth employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Operations Manager in Plymouth
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Vertex or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of GMP and quality assurance principles. We want you to showcase your expertise, so practice discussing your experience with batch records and compliance!
✨Tip Number 3
Don’t forget to highlight your problem-solving skills during interviews. Share specific examples of how you've tackled challenges in QA operations. This will show them you’re not just knowledgeable but also proactive!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are keen to join us directly. Let’s make it happen!
We think you need these skills to ace Quality Assurance Operations Manager in Plymouth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Operations Manager role. Highlight your experience with GMP batch disposition and any relevant QA support you've provided in manufacturing operations. 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 experience with batch record review and compliance – that’s key for us!
Showcase Your Problem-Solving Skills: In your application, be sure to highlight your critical thinking and problem-solving abilities. Share examples of how you've successfully led investigations or managed CAPAs in the past. We love seeing candidates who can tackle challenges head-on!
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 Inside Out
Make sure you brush up on your knowledge of quality assurance principles and compliance, especially in the context of GMP manufacturing. Be ready to discuss your experience with batch record review and how you've handled deviations or CAPAs in the past.
✨Familiarise Yourself with Relevant Technologies
Since the role involves using network-based applications like Oracle, TrackWise, and Veeva, it’s crucial to demonstrate your familiarity with these tools. If you’ve used them before, prepare specific examples of how they helped you in your QA processes.
✨Prepare for Scenario-Based Questions
Expect questions that assess your critical thinking and problem-solving skills. Think of scenarios where you had to lead investigations or make decisions based on risk assessments, and be ready to explain your thought process and outcomes.
✨Show Your Collaborative Spirit
This role requires working closely with cross-functional teams and stakeholders. Prepare to share examples of how you've successfully collaborated in the past, particularly in a QA context, and how you can act as a trusted advisor in compliance matters.