- Supports for quality oversight of Vertex Cell and Gene Therapy manufacturing operations across all phases of development and commercial, support of analytical laboratory, materials management, and facility/engineering groups.
- 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 QA execution of process and OOS investigations, and associated CAPAs .
- Responsible 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.
- Participate s 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 r isks and gaps for GMP process es .
- Record and m aintain 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, protocol and test data review and manufacturing process/SOP improvements .
- Bachelor's degree in a biotech / Lifesciences field.
- Demonstrated experience providing QA support and oversight of 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
- 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.
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Cell and Gene Therapy Operational Quality Sr Specialist - London, United Kingdom - Vertex Pharmaceuticals
Description
Cell and Gene Therapy Operational Quality Sr Specialist page is loaded
Cell and Gene Therapy Operational Quality Sr Specialist
Apply locations Paddington, United Kingdom time type Full time posted on Posted 3 Days Ago job requisition id REQ-21254Job Description
This role is recognized as an expert internally in the principles and application of quality assurance and compliance. The person will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external Cell & Genetic Therapeutic programs . This role will 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 & Responsibilities
Required Education Level
Required Knowledge/Skills
Other Requirements
Please indicate required certifications, licenses or specialized trainings .
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at
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locations Paddington, United Kingdom time type Full time posted on Posted 30+ Days AgoVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune's 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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Cell and Gene Therapy Operational Quality Sr Specialist professionals in London
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Zoe Whiteley
Final year PhD student at UCL
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Arushi Sharma
Analyst