Quality Systems Specialist, Biotech (GxP & eQMS)

Spur Therapeutics Limited; Stevenage; On-site; GBP 45,000 - 65,000; Full time

Job summary

Spur Therapeutics Limited in Stevenage, UK is seeking a skilled Quality Assurance Specialist - Quality Systems to enhance and maintain our QMS, with a strong focus on eQMS administration and regulatory compliance. The role works cross-functionally to ensure GDP, GMP, and data integrity across quality processes.

The successful candidate will bring at least five years of QA experience in gene therapy or related biologics environments, strong documentation discipline, and the ability to drive

Qualifications

• Bachelor’s degree in a scientific, engineering, life sciences, or related discipline is preferred.
• Minimum of 5 years of Quality Assurance experience with emphasis on Quality Systems.
• Hands-on experience with an electronic Quality Management System (eQMS).
• Experience with document control, training, deviations, investigations, CAPA, supplier quality, and change control.
• Experience in biologics, cell therapy, or gene therapy environments is desirable.

Responsibilities

• Support administration, maintenance, and continuous improvement of the Quality Management System (QMS).
• Serve as administrator for the electronic Quality Management System (eQMS).
• Support configuration, implementation, and optimization of eQMS workflows and processes.
• Monitor quality system activities ensuring records are managed within timelines.
• Maintain Quality System metrics and identify trends and improvement opportunities.
• Assist with audits, supplier audits, and regulatory inspection readiness.

Skills

Communication skills

Attention to detail

Organizational skills

Problem solving

Analytical skills

Cross-functional collaboration

Education

Bachelor’s degree in science/engineering/life sciences

Equivalent combination of education and relevant pharma experience

Tools

Compliance Quest

Veeva Vault Quality

MasterControl

TrackWise Digital

Job description

Spur Therapeutics Limited in Stevenage, UK is seeking a skilled Quality Assurance Specialist - Quality Systems to enhance and maintain our QMS, with a strong focus on eQMS administration and regulatory compliance. The role works cross-functionally to ensure GDP, GMP, and data integrity across quality processes.

The successful candidate will bring at least five years of QA experience in gene therapy or related biologics environments, strong documentation discipline, and the ability to drive