Computer System Validation Lead

This position is responsible for direct interaction with internal customers to determine hardware, software and system requirements. Ensures SDLC, ASLM, FDA, and SOX compliance for IT Projects in every portfolio. The position will define and analyze system needs/problems; design and test standards and solutions, create SDLC documentation, and ensure validation documentation meets requirements

Essential Functions

• Performs and oversees software project validation in line with departmental SOPs and guidelines.
• Ensures SDLC validation documentation content is complete, maintained and meets GxP/FDA requirements.
• Authoring and/or contributing to all validation deliverables including Plan, Requirements, Test Plan, Design, Protocols, Traceability Matrix, Baseline, Reports and Standard Operating Procedures (SOPs).
• Assesses company’s computer systems and identifies any potential GxP or FDA Part 11 gaps
• Participates in regulatory audits and provides information on validation activities performed for Q2 computer systems.
• Providing standardized templates, guidance, and overall validation direction supporting various programs
• Reviews internal and external requirements and implements required processes as needed to meet expectations regarding Quality
• All other System Validation Team processes and tasks as needed

Qualifications

• Bachelor's Degree in Computer Science, a related field or equivalent experience in a medical, clinical, pharmaceutical or analytical setting
• Over Seven (7) years related experience in Software Validation in a medical, clinical, pharmaceutical or analytical setting
• Excellent communication skills in English
• Experience with FDA, GxP, Part 11 and SOX validation rules and regulations

Desired Technical Abilities

• HP ALM
• Jira / ADO
• Software Validation
• SDLC
• SQL / Oracle
• API

Q² Solutions,IQVIA’s laboratory business, creates connected intelligence by combining our expertise, technology and analytics - this fuels unparalleled research & development solutions. We uphold a deep commitment to patients, sites, customers, and each other. https://www.q2labsolutions.com/careers