Quality Assurance Engineer IT systems (f/m/d)

Our client Science 37 has developed a cloud based clinical research platform that is used by both external and internal staff to run distributed clinical trials. Your success as a Quality Assurance Engineer will be evaluated based on your ability to support quality compliance operations for the clinical research platform. Responsible for ensuring the overall compliance for GxP systems developed/utilized at Science 37.

Duties include but are not limited to:
• Assure quality systems are followed and integrated with business processes and aligned with Science 37 systems and external regulatory requirements
• Provide interpretation, guidance, and training regarding qualification and validation requirements in GxP
• Apply Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
• Participate in project teams and author (as applicable), review and approve computer validation related documentation including but not limited to: risk assessments, validation plan, user requirements, specifications, UAT, traceability matrix, testing (FAT, SAT, IQ,, OQ/PQ), data migration, qualification/validation protocols and reports.
• Participate/lead in the review of current and future SDLC/CSV policies and procedures.
• Support initiatives related to audit readiness, management of internal audits and regulatory inspections, and responding to findings in areas of responsibility
• Demonstrate strong proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new product or process introductions, as well as process and business improvements.
• Implement, and/or maintain process Quality control plans that are in accordance with product or process risk level, and ensures those plans are consistently followed.
• Support execution of strategic vision or plan by collaborating with cross functional teams to identify required Quality Engineering skills and competencies.
• Actively coach talent across the tech organization on quality principles
• Partner with training to prepare user documentation and training materials

The position offers:
• Exiting career opportunity with a US-based global leader in virtual clinical trials
• Growing environment and interesting career prospects
• Unique opportunity to deliver clinical trials of the future: decentralized/virtual clinical trials
• Remote work and the possibility of working from a corporate office in the near future
• Strong international management and team support
• Start-Up work environment (establishing business in Europe)
• Top-notch equipment such as the latest MacBook and monitor
• Competitive compensation and benefits

Please apply directly via our hiring portal: https://erecruiter0051.kandidatenportal.eu/Job/130014