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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 and scientific innovation.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career development.
- Why this job: Join a dynamic team making a real difference in the biotech field.
- 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 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.
Qualifications:
- 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.
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 Manager - Operations in City of London employer: Vertex Pharmaceuticals
Contact Detail:
Vertex Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager - Operations in City of 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 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 and how it aligns with Vertex's mission in cell and gene therapy.
✨Tip Number 3
Don’t forget to follow up after your interview! A quick thank-you email can keep you fresh in their minds and show your enthusiasm for the role. We love seeing candidates who are proactive!
✨Tip Number 4
Apply through our website for the best chance! We’ve got all the latest openings, and applying directly can sometimes give you an edge over other candidates. Let’s get you that Quality Assurance Manager role!
We think you need these skills to ace Quality Assurance Manager - Operations in City of London
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 passionate about quality assurance and how your background makes you a perfect fit for this position. Let us know what excites you about working with Vertex.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've improved processes or resolved compliance issues in previous roles. We love seeing quantifiable results!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Let’s get your application rolling!
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 review, deviations, and CAPA.
✨Familiarise Yourself with the Company
Research Vertex Pharmaceuticals and their focus on cell and gene therapies. Understanding their mission and recent developments will help you tailor your responses and show genuine interest in the role and the company.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, particularly around event investigations and root cause analysis. Prepare to share detailed examples of how you've handled compliance risks or led cross-functional teams in the past.
✨Showcase Your Communication Skills
As a Quality Assurance Operational Manager, you'll need to communicate effectively with various stakeholders. Practice articulating complex quality concepts clearly and concisely, and be prepared to discuss how you've collaborated with others to drive continuous improvement.