Cell and Gene Therapy Operational Quality Sr Specialist

4 weeks ago

London, United Kingdom Vertex Full time

Job 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 

  • 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. 

  • 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, protocol and test data review and manufacturing process/SOP improvements.

 

Required Education Level

  • Bachelor's degree in a biotech/ Lifesciences field. 

Required Knowledge/Skills

  • 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.

Other Requirements 
Please indicate required certifications, licenses or specialized trainings.  

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