Quality Manager, ATC Operational Quality

Salary not available. View on company website.

Vertex Pharmaceuticals, Paddington, Greater London

Full time
Contract
Onsite working

Posted 2 days ago, 27 Aug | Get your application in today.

Closing date: Closing date not specified

Job ref: 2f444195bff449689bc53e959a5ef6fc

Location ref: Paddington, Greater London

Vertex Pharmaceuticals

Full Job Description

Quality Manager, ATC Operational Quality Quality Manager, ATC Operational Quality Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Vertex Pharmaceuticals Company Name: Vertex Pharmaceuticals Type of Role: Contract position, Inside IR35 Contract length: 12 months Location: London, Paddington Department: Quality Assurance 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 Apheresis Quality Operations Manager will support the activation of commercial gene therapy Authorized Treatment Centers. The role will perform quality risk assessments and assist with completion of quality agreements, provide operational support for commercial site selection and activation of apheresis and cell-therapy laboratory centers. This role will be supporting the activation of the Authorized Treatment Centers (commercial sites) and will work closely with the Apheresis and Infusion Operations team and the QA Audit team in qualifying sites partnering to provide life saving cell and gene therapy to patients in need. The Quality 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. The Quality Manager is responsible to support real time treatment center assessment activities within VCGT Quality. The Quality Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment. Key Duties and Responsibilities:

Work closely with the Audit and Inspection quality function to establish the audit strategy for Auditing and Performance oversight to evaluate treatment centers ensuring compliance with standards established by applicable regulatory, licensing, and accrediting bodies
Conduct treatment center Audits where required
Actively engage with the Audit Management, Vender Management and Apheresis Infusion Operations functions on site qualifications
Establish and maintain Quality Agreements
Work with the business areas on site selection
Provide QA support of change controls, investigations, CAPA's and effectiveness checks
Responsible for identifying risks and communicating gaps for process/systems
Coordinate preparation activities with SMEs
Real-time Inspection Readiness
Develop, utilize, and continue to mature tools to ensure efficiency in execution
Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes
Identify areas of improvement and participate in process improvement initiatives
Additional as needed support to processes, systems, procedures to ensure continuous Quality improvement
Additional activities as needed to support the Quality Systems
Author/Revise Standard Operating Procedures and associated forms.
Strong apheresis and/or cellular therapy Quality or Operations background
Project Management Skills
Operational QA experience with experience with the following is preferred:
Inspection support roles
Quality System background
Understanding of GMP/GDPs/GTP and applicable guidelines/guidance
Ability to collaborate with cross-functional teams
Excellent technical writing, presentation, and communication skills
Experience conducting investigations, performing Root Cause Analysis, and identifying CAPA
Bachelor's / Masters degree required
Background in Quality Assurance supporting apheresis, transplant, or cell-therapy lab in a biotech/pharma or healthcare setting
Seniority levelNot Applicable
Employment typeContract
Job functionQuality Assurance
IndustriesBiotechnology Research and Pharmaceutical Manufacturing

Strong apheresis and/or cellular therapy Quality or Operations background
Project Management Skills
Operational QA experience with experience with the following is preferred:
Inspection support roles
Quality System background
Understanding of GMP/GDPs/GTP and applicable guidelines/guidance
Ability to collaborate with cross-functional teams
Excellent technical writing, presentation, and communication skills
Experience conducting investigations, performing Root Cause Analysis, and identifying CAPA
Bachelor's / Masters degree required
Background in Quality Assurance supporting apheresis, transplant, or cell-therapy lab in a biotech/pharma or healthcare setting

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.

Direct job link

https://www.jobs24.co.uk/job/quality-manager-atc-operational-quality-127284462