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IT Risk & Compliance Engineer GxP

Avelsen · Lyon, France · Hybrid · Senior

  • Lyon, France · Hybrid
  • French

Indexed (today) · refreshed constantly

Start
flexible
Work mode
Hybrid
Contract
Freelance / B2B
Seniority
Senior

Required skills

Languages: French

Job description

Our client, a major pharmaceutical group, is looking for a risk and compliance profile with a strong technical culture to support its digital teams. The goal is to integrate compliance from the design phase rather than validating it afterwards.

Project overview

Context

Our client, a major pharmaceutical group, is accelerating the pace of its digital teams: its products are released continuously, and risk and compliance decisions are now made at each sprint.

To ensure that compliance keeps pace without slowing down the teams, they are looking for a risk and compliance profile with a real technical culture. Integrated into the product teams, this person will be their daily risk referent and will liaunt with the group's compliance experts. The objective is to integrate compliance from the design phase rather than validating it afterwards.

Responsibilities

Practical information

  • Be the risk and compliance referent for product teams: participate in their rituals (planning, refinement, reviews) and anticipate risk issues based on roadmaps
  • Define and evolve product risk profiles, and support the implementation of controls (GxP pharma quality, cybersecurity, data protection)
  • Review release reports and validation deliverables with the teams, using an approach adapted to agile and continuous delivery
  • Automate what can be automated: traceability, evidence collection, reporting, within the teams' pipelines and tools
  • Evaluate supplier risk (SaaS, cloud) with the relevant teams
  • Carry out control attestations, prepare audits and inspections, and monitor action plans
  • Train the teams and report to management on the status of risks and releases
  • Freelance, long-term mission
  • Lyon, with regular on-site presence

Project details

  • Start: flexible
  • Remote: hybrid
  • Location: Lyon, France, FR
  • Languages: French

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