At a Glance
- 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: Join a dynamic team focused on continuous improvement and innovation.
- Why this job: Make a real impact in the biotech field while working on cutting-edge therapies.
- 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 London employer: LinkedIn
Vertex Pharmaceuticals is an exceptional employer, offering a dynamic work environment in the heart of Paddington, London. With a strong commitment to scientific innovation and employee development, Vertex fosters a culture of collaboration and continuous improvement, providing ample opportunities for professional growth in the biotechnology sector. Employees benefit from a hybrid working model, competitive compensation, and the chance to contribute to transformative medicines that make a real impact on patients' lives.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Assurance Operations Manager in London
✨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 insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and quality assurance principles. We recommend practising common interview questions and scenarios related to batch record reviews and compliance issues.
✨Tip Number 3
Showcase your problem-solving skills! Be ready to discuss specific examples where you've led investigations or implemented CAPAs. This will demonstrate your hands-on experience and critical thinking abilities.
✨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 want to make an impact in the biotech field.
We think you need these skills to ace Quality Assurance Operations Manager in London
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 records and compliance, as these are key for this position. 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 in cell and genetic therapies makes you a perfect fit. Let’s show them that you’re not just another applicant!
Showcase Relevant Experience:When filling out your application, be sure to showcase any relevant experience you have with batch record review, CAPA, and event investigations. We want to see concrete examples of how you've tackled similar challenges in the past.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love to keep things simple and straightforward for you!
How to prepare for a job interview at LinkedIn
✨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 prepared to discuss specific examples from your past experience where you've successfully navigated batch record reviews or led investigations.
✨Familiarise Yourself with the Company
Research Vertex Pharmaceuticals and their focus on transformative medicines. Understanding their mission and recent developments in cell and gene therapy will help you align your answers with their goals and demonstrate your genuine interest in the role.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle compliance risks. Think of scenarios where you've had to make critical decisions or lead cross-functional teams, and be ready to explain your thought process and outcomes.
✨Showcase Your Communication Skills
As a Quality Assurance Operations Manager, effective communication is key. Prepare to discuss how you've collaborated with stakeholders and contract manufacturers in the past. Highlight your ability to convey complex information clearly and build trust within teams.
