Software Validation Testing, Compliance Lead

Job Overview
Ensures SDLC, ASLM, FDA, and SOX compliance for IT Projects in every portfolio.

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 Five (5) 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
• Ability to travel to Q2 Solutions sites for in-person audit support as required

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $105,000.00 - $157,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.