Quality Assurance Officer at Replimune, Inc.
London, London - England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

26 Jan, 27

Salary

40000.0

Posted On

28 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Yes

Skills

Industry

Hospitals & Health Systems

Description

This is a hands-on RAQA role for someone early in their career. You will help keep our quality management system running reliably, draft clear procedures under the Head of RAQA’s review, and contribute to medical-device and IVD regulatory documentation.

You must be based in London. Our setup is hybrid, with office attendance normally around two to three days a week; the precise arrangement is flexible and agreed with the team. Travel to our laboratory in Liège is expected roughly once a quarter.

The role combines careful execution with a strong improvement mindset. We want someone who questions unnecessary manual work and uses AI to make useful workflows faster and more repeatable, while preserving accuracy, traceability and required review.

MAIN RESPONSIBILITIES

  • • Maintain document-control trackers, approval status, training records and onboarding documentation. Make upcoming deadlines and missing evidence visible.• Keep non-conformity and CAPA records up to date, follow up actions and escalate overdue items or unresolved issues.• Support supplier qualification and evaluation records, tracking renewals, approvals and gaps.• Prepare evidence and documentation for internal and external audits, quality trend reporting and management review.• Draft and update SOPs, work instructions, forms and templates under the review and approval of the Head of RAQA.• Contribute to IVDR quality-system expansion, technical documentation, labelling and instructions for use. Programme ownership and regulatory approval remain with the relevant senior reviewers.• Support validation documentation for quality and laboratory software tools under supervision.• Monitor relevant regulatory guidance and standards, and explain their practical implications to the team.• Improve repetitive administrative and documentation work using AI, reusable skills and simpler processes. Check outputs against sources and preserve required quality controls.
Responsibilities
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