Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure quality assurance in biotech manufacturing and support compliance activities.
- Company: Vertex Pharmaceuticals, a leader in transformative medicines.
- Benefits: Hybrid work model, competitive pay, and opportunities for professional growth.
- Why this job: Join a pioneering biotech firm and make a real difference in patients' lives.
- Qualifications: Degree in biotech/life sciences and experience in GMP quality assurance.
- Other info: Dynamic role with potential for impactful contributions in a collaborative environment.
The predicted salary is between 48000 - 72000 £ per year.
Company Name: Vertex Pharmaceuticals
Type of Role: Contract position, Inside IR35
Contract length: 12 months
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.
General Summary
This role is recognized as an expert internally in the principles and application of quality assurance and compliance. The person will provide QA support for manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs. This role will be primarily focused on batch record review, archival & support activities related to product disposition activities.
Key Duties & 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.
- Support in archiving activities.
- Support QA execution of process and OOS investigations, and associated CAPAs.
- Support for approval of COAs and product labelling.
- Provide manufacturing support and guidance for GMP product quality impact assessments at the Contract Manufacturers.
- Support GMP release of incoming raw material and components.
- Participates and supports in compliance activities and help drive the closure of any observations by partnering with Vertex Compliance and Quality Assurance for CDMO and CTO activities.
- Responsible for identifying compliance risks and gaps for GMP processes.
- Record and maintain daily/monthly/quarterly batch record metrics and assists department with required Quality System data review metrics and reporting.
- Support Cell & Genetic Program and Quality projects including Quality system, and manufacturing process/SOP improvements.
Required Knowledge/Skills
- Bachelor's degree in biotech/life sciences field.
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
- Demonstrated experience in batch review/batch disposition of sterile products, biologic products and/or ATMPs.
- 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.
- Ability to evaluate quality matters and make decisions utilizing risk-based approach.
- Ability to facilitate cross-functional meetings/projects 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.
GMP Operational Quality Senior Specialist employer: Talent Works
Contact Detail:
Talent Works Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Operational Quality Senior Specialist
✨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 GMP knowledge and compliance standards. We want you to showcase your expertise in batch record review and quality assurance, so be ready to discuss real-life examples!
✨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. Plus, it’s a great chance to reiterate why you’re the perfect fit.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets noticed and shows you’re serious about joining the team at Vertex. Let’s make it happen!
We think you need these skills to ace GMP Operational Quality Senior Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the GMP Operational Quality Senior Specialist role. Highlight your relevant experience in quality assurance and compliance, especially in batch record review and GMP processes. 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 the role and how your background makes you a perfect fit. Don’t forget to mention any specific experiences that relate to the key duties outlined in the job description.
Showcase Your Skills: In your application, be sure to showcase your critical thinking and problem-solving skills. Mention any experience you have with event investigations or CAPA, as these are crucial for the role. We love seeing candidates who can demonstrate their expertise!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way to ensure your application gets noticed by the right people at Vertex. Plus, it shows you’re serious about joining the team!
How to prepare for a job interview at Talent Works
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and how they apply to the role. Be ready to discuss specific examples from your past experience where you've successfully navigated GMP compliance, especially in batch record review and product disposition.
✨Showcase Your Problem-Solving Skills
Prepare to share instances where you've led event investigations or conducted Root Cause Analysis. Vertex is looking for someone who can think critically and solve problems effectively, so have a few solid examples ready that highlight your analytical skills.
✨Familiarise Yourself with Relevant Tools
Since the role involves using network-based applications like Oracle, TrackWise, and Veeva, it’s a good idea to familiarise yourself with these tools. If you have experience with them, be prepared to discuss how you’ve used them in previous roles to enhance quality assurance processes.
✨Communicate Effectively
Vertex values effective communication, especially in cross-functional settings. Practice articulating your thoughts clearly and concisely. Think about how you can demonstrate your ability to facilitate meetings and collaborate with stakeholders during the interview.
