Computer System Validation Lead

Regulatory and Quality Solutions LLC (R&Q) Europe - Remote Full-time

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The role is responsible for planning, writing, implementing, and reviewing computer system validation protocols of computerized systems for business balanced solutions.
The role will serve as the subject matter expert for computerized systems validation, electronic records & signatures, and data integrity requirements for RQM+.

Primary 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.
  • Maintain knowledge and understanding of quality system requirements as they apply to computerized system in accordance with appropriate regulations and industry standards / best practices.

Education/Work Experience

  • Bachelor’s level degree required
  • Minimum of 8-10 years related work experience
  • Experience in GxP, CRO, Laboratory, or R&D environments

Key Requirements

  • 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

Supervisory Responsibilities

  • This position may have supervisory responsibilities

Work Environment / Physical Demands

  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.