RQM+ is hiring a
Computer System Validation Lead

Summary

Join RQM+, the leading MedTech service provider, as a Computer System Validation Specialist to plan, write, implement, and review computer system validation protocols. As a subject matter expert, you will lead all associated assessments, develop documentation, facilitate communication, and maintain knowledge of quality system requirements.

Requirements

• Bachelor’s level degree required
• Minimum of 8-10 years related work experience
• Experience in GxP, CRO, Laboratory, or R&D environments
• Strong business analysis skills
• Knowledge across a range of GxP supporting SaaS products
• Knowledge of managing internally developed and non-SaaS products
• Fundamental understanding of GAMP 5, FDA (GMP), GLP, and EU Annex 11 requirements of computerized systems
• Ability to effectively promote and facilitate organization change

Responsibilities

• Coordinate all computerized system validation activities and lead all associated assessments
• Develop, review, and/or approve of system validation and infrastructure qualification documentation including master plans, user requirements and functional requirements, design specifications, user acceptance tests, and more
• Facilitate communication between Information Technology and system owners to effectively and efficiently implement, upgrade, or modify computerized systems
• Review change control requests and assess impact to validation. Support the necessary computerized system validation activities for changes
• Lead or participate in supplier audits and work to address and improve systems and processes
• Generate, review, and update CSV related policies, procedures, templates, and forms

Benefits

• Industry leading compensation package
• Deeply engrained focus on work life balance