Computer System Validation Lead

il y a 1 semaine

Paris, Île-de-France Regulatory and Quality Solutions LLC (R&Q) Temps plein

RQM+ is a leading MedTech service provider with a global team of regulatory and quality experts. Our 40 years of regulatory expertise have enabled us to provide comprehensive clinical trial, lab, and reimbursement services, reducing risk and supporting market access throughout the product lifecycle for medical devices, digital therapeutics, and diagnostics.

The role is responsible for planning, writing, implementing, and reviewing computer system validation protocols for computerized systems. As a subject matter expert, you will lead computerized systems validation, electronic records & signatures, and data integrity requirements for RQM+.

Key Responsibilities
  • Coordinate computerized system validation activities and lead associated assessments.
  • Develop, review, and approve system validation and infrastructure qualification documentation.
  • Facilitate communication between IT and system owners to implement, upgrade, or modify computerized systems.
  • Review change control requests and assess impact to validation.
  • Lead or participate in supplier audits and improve systems and processes.
  • Generate, review, and update CSV-related policies, procedures, templates, and forms.
Requirements
  • Bachelor's degree required.
  • Minimum 8-10 years related work experience.
  • Experience in GxP, CRO, Laboratory, or R&D environments.
What We Offer
  • Industry-leading compensation package.
  • Deep focus on work-life balance.
  • Ongoing learning and development opportunities.

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

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