GXP Quality Senior Manager

Company Name: Vertex Pharmaceuticals

Type of Role: Contract position, Inside IR35

Contract length: 12 months

Location: London, Paddington

Department: 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:

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 and assist with completion of quality agreements, provide operational support for commercial Cell and Gene Therapy starting material movement, working closely with the ATC Quality Operations team and Supply Chain team in managing distributors and transportation companies.

The Senior Manager will complete the execution of the quality Risk Management Plans that will govern the monitoring and oversight by QA and business functions, working closely with the business stakeholders and the functions within the Quality organization with the objective of ensuring transparency for gaining insights regarding operational risks and mitigations.

This individual is expected to demonstrate success in engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence through business and Quality.

Key Duties and Responsibilities:

• The position is responsible to ensure the successful execution, but is not limited to the following:
• Serve as the primary Quality contact for the Global oversight of Cell and Gene starting material movement.
• Manage for cause, critical and/or complex quality issues in the starting material movement operations and supports CMC quality teams investigating any potential product quality issues.
• Act as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GXP actions.
• Executes data analysis and reports KPIs into the local and global GDP and GMP management review processes.
• Responsible for the Quality oversight and management of Cell and Gene Therapy curriers/transportation companies and distributors: creating and maintaining Quality Agreements, developing KPIs and establishing Quality meetings.
• Participate in Geographic expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments.
• Support implementation of effective global shipping qualification process.
• Support Recalls, mock recalls and any other on-market activity.
• Support and participate in regulatory inspections relating to GTP, GDP and GMP.
• Responsible for identifying risks and communicating gaps for process/systems.
• Develop, utilize, and continue to mature tools to ensure efficiency in execution.

Minimum qualifications:

• Bachelor’s Science degree or equivalent degree
• Quality Functions background, ideally in cell and gene therapy, in Pharmaceutical Industry

Preferred Qualifications/Experience:

• Thorough understanding of regulatory framework for Cell and Gene Therapy medicinal products, and able to navigate industry developments and providing key strategic guidance to the business.
• A real 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.