Company Name:
Vertex Pharmaceuticals
Type of Role:
Contract position, Inside IR35
Contract length:
12 months
Location:
London, Paddington
Department:
Quality Assurance
Overview:
Vertex, a global biotechnology company, is seeking a Quality Operations Manager to support the activation of commercial gene therapy treatment centers. This role involves performing quality risk assessments, supporting site selection and activation, and collaborating with cross-functional teams to ensure compliance and operational excellence in providing cell and gene therapy.
Key Responsibilities:
* Coordinate with audit and quality functions to establish audit strategies and conduct treatment center audits.
* Engage with vendor management and operations on site qualifications.
* Develop and maintain quality agreements and support site selection processes.
* Provide QA support for change controls, investigations, CAPAs, and effectiveness checks.
* Identify risks, communicate gaps, and support process improvements.
* Assist in inspection readiness activities and develop tools for efficiency.
* Support continuous quality improvement initiatives and document SOPs.
Required Skills and Knowledge:
* Strong background in apheresis and/or cellular therapy quality or operations.
* Project management and operational QA experience, including inspection support roles.
* Knowledge of GMP, GDP, GTP, and relevant guidelines.
* Effective collaboration, communication, and technical writing skills.
* Experience with investigations, root cause analysis, and CAPA processes.
Education and Experience:
* Bachelor’s or Master’s degree required.
* Experience supporting apheresis, transplant, or cell-therapy labs in biotech, pharma, or healthcare settings.
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