Senior QA Auditor - Part-Time, Hybrid (GCP/GMP)

Healx; Cambridge; Hybrid; GBP 60,000 - 90,000; Part time

Benefits offered by this job

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7% employer pension contributions

Life insurance 4x base salary

Private medical insurance

25 days annual leave

Job summary

Healx, a Cambridge-based AI-powered biotech company, seeks a Senior QA Auditor (part-time 60%–80%) to lead analytical QA activities ensuring GCP and GMP compliance across clinical and manufacturing. You’ll work with the Clinical team to keep Healx inspection-ready and drive continuous QMS improvements, coordinating with CMC, Regulatory Affairs and Operations.

You will develop SOPs, manage audits, CAPAs and risk planning, and support regulatory submissions.

Qualifications

• Bachelor’s degree in Science, Life Science or Health related field, or in Quality Management.
• Deep understanding of ICH-GCP and GMP guidelines, working knowledge of EU directives/regulations.
• Strong analytical, problem-solving and decision-making abilities.
• Willingness to travel to the US (once or twice a year).
• Hands-on and collaborative approach to strong analytical, problem-solving.

Responsibilities

• Develop, write and maintain SOPs in line with ICH-GCP and GMP guidelines.
• Maintain and improve the Quality Management System (QMS) and training records.
• Prepare and execute the annual audit plan and manage vendor qualification.
• Be inspection-ready and advise on corrective and preventive actions (CAPAs).
• Liaise with Regulatory Affairs for Health Authority inspections.
• Assist in risk management planning and cross-functional QA activities.

Skills

Analytical thinking

Problem solving

Decision making

Communication

Interpersonal skills

Willingness to travel to US

Hands-on

Biotech / techbio interest

Education

Bachelor’s degree in Science or Life Science

Tools

eQMS

Job description

Healx, a Cambridge-based AI-powered biotech company, seeks a Senior QA Auditor (part-time 60%–80%) to lead analytical QA activities ensuring GCP and GMP compliance across clinical and manufacturing. You’ll work with the Clinical team to keep Healx inspection-ready and drive continuous QMS improvements, coordinating with CMC, Regulatory Affairs and Operations.

You will develop SOPs, manage audits, CAPAs and risk planning, and support regulatory submissions.