eQMS & GxP Quality Lead – Audit-Ready Operations

Bicycle Therapeutics; Cambridge; On-site; GBP 55,000 - 80,000; Full time

Benefits offered by this job

Pension (10% employer contribution)

Private Medical Insurance

Health Cash Plan

Cycle to Work

Flexible working

Annual bonus

Job summary

Bicycle Therapeutics is looking for an experienced eQMS administrator to join our R&D Quality team in Cambridge, UK. You will manage the electronic Quality Management System, ensure GxP document control, training compliance, CAPA tracking, and inspection readiness across development programs.

The role requires deep knowledge of validated eQMS platforms (Veeva Vault, TrackWise, MasterControl) and experience supporting regulatory audits.

Qualifications

• Experience administering eQMS and GxP document control
• Experience supporting regulatory inspections (FDA/MHRA/EMA)
• Strong attention to detail and organizational skills

Responsibilities

• Administer and maintain the eQMS for R&D quality.
• Oversee GCP/GLP/GPV document control and study training matrices.
• Manage CAPA tracking and evidence collection.
• Support audit and inspection readiness, including inspections.
• Provide system training and user support.

Skills

eQMS administration

GxP knowledge

Regulatory compliance

Cross-functional collaboration

Tools

Veeva Vault

TrackWise

MasterControl

Dot Compliance

Job description

Bicycle Therapeutics is looking for an experienced eQMS administrator to join our R&D Quality team in Cambridge, UK. You will manage the electronic Quality Management System, ensure GxP document control, training compliance, CAPA tracking, and inspection readiness across development programs.

The role requires deep knowledge of validated eQMS platforms (Veeva Vault, TrackWise, MasterControl) and experience supporting regulatory audits.