Overview

Company Name:

Vertex PharmaceuticalsType of Role:

Contract position, Inside IR35Location:

London, PaddingtonDepartment:

QualityVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. As they grow their pipeline, they are strengthening their reputation for creating transformative medicines for people with serious diseases.General Summary

The GXP Senior Manager is responsible for oversight of activities and ensuring quality of deliverables within their purview. This role is recognized as a technical resource in the principles and application of quality assurance. The successful applicant will perform quality risk assessments, assist with the completion of quality agreements, and provide operational support for commercial Cell and Gene Therapy starting material movement. They will work closely with the ATC Quality Operations team and Supply Chain team in managing distributors and transportation companies. The Senior Manager will execute the quality Risk Management Plans, governing monitoring and oversight by QA and business functions, with the objective of ensuring transparency for insights into operational risks and mitigations. This individual should demonstrate the ability to engage teams and stakeholders to advance quality outcomes and operational excellence through business and Quality functions.Key Duties and Responsibilities

Serve as the primary Quality contact for the global oversight of Cell and Gene Therapy starting material movement.Manage for-cause, critical, and/or complex quality issues in starting material movement operations and support CMC quality teams investigating potential product quality issues.Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, and strategy for GXP actions.Execute data analysis and report KPIs into local and global GDP and GMP management review processes.Oversee quality of Cell and Gene Therapy carriers/transportation companies and distributors: create and maintain Quality Agreements, develop KPIs, and establish Quality meetings.Participate in geographic expansion activities to ensure Quality-related actions are planned into projects and completed in line with commitments.Support implementation of an effective global shipping qualification process.Support recalls, mock recalls, and other on-market activities.Support regulatory inspections relating to GTP, GDP and GMP.Identify risks and communicate gaps for processes and systems.Develop, utilize, and mature tools to improve execution efficiency.Quality Functions background, ideally in cell and gene therapy, in the pharmaceutical industry.Preferred Qualifications/Experience

Thorough understanding of regulatory framework for Cell and Gene Therapy medicinal products, with ability to navigate industry developments and provide strategic guidance to the business.Subject matter expert on all aspects related to GXP within pharmaceutical distribution.Ability to collaborate with cross-functional teams.Excellent technical writing, presentation, and communication skills.Extensive experience conducting investigations, performing Root Cause Analysis, and identifying CAPA.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.Employment Details

Seniority level: Not ApplicableEmployment type: ContractJob function: Quality AssuranceIndustries: Biotechnology Research and Pharmaceutical Manufacturing

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