eQMS Quality Lead - GxP, CAPA & Audit Readiness

Bicycle Therapeutics; Cambourne; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Pension (10%)

Private Medical Insurance

Health Cash Plan

Group Life Assurance

Cycle to Work

Gym membership

Flexible working

Job summary

Bicycle Therapeutics seeks an experienced eQMS and QA operations professional to administer and optimize our electronic Quality Management System in R&D. You will oversee GxP document control, training matrices, CAPA tracking, and inspection readiness across clinical programs.

Responsibilities include system ownership, data extraction, and cross-functional collaboration with HR, IT, and study teams to ensure compliance with ICH GCP and 21 CFR Part 11.

Qualifications

• Demonstrated expertise administering validated eQMS platforms and GxP documentation.
• Experience coordinating training matrices and qualification records across global teams.

Responsibilities

• eQMS administration and GxP document lifecycle control.
• Training management and compliance oversight across study teams.
• Deviation, CAPA, and quality event support throughout clinical development.
• Audit and inspection readiness support including regulatory interactions.

Skills

eQMS administration

GxP document control

CAPA tracking

Training management

Regulatory knowledge

Tools

Veeva Vault

TrackWise

MasterControl

Dot Compliance

Job description

Bicycle Therapeutics seeks an experienced eQMS and QA operations professional to administer and optimize our electronic Quality Management System in R&D. You will oversee GxP document control, training matrices, CAPA tracking, and inspection readiness across clinical programs.

Responsibilities include system ownership, data extraction, and cross-functional collaboration with HR, IT, and study teams to ensure compliance with ICH GCP and 21 CFR Part 11.