Quality Manager, ATC Operational Quality

Talent Works; Lytham St Annes; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology company is seeking a Quality Operations Manager to enhance gene therapy treatment centers. Responsibilities include managing audits, supporting quality agreements, and ensuring compliance. Candidates should have operational QA experience and a relevant degree. This is a contract position for 12 months based in London, Paddington.

Qualifications

• Strong background in apheresis and/or cellular therapy quality or operations.
• Experience with GMP, GDP, GTP, and relevant guidelines.
• Experience supporting apheresis, transplant, or cell-therapy labs.

Responsibilities

• Coordinate with audit functions for treatment center audits.
• Engage with vendor management on site qualifications.
• Develop and maintain quality agreements.
• Provide QA support for change controls and investigations.
• Identify risks and support process improvements.
• Assist in inspection readiness activities.

Skills

Apheresis quality experience

Operational QA experience

Project management skills

Effective communication skills

Technical writing skills

Investigation and analysis

Education

Bachelor’s or Master’s degree

Job description

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.