The Solution Owner Quality Management System (Regulatory & Quality) oversees the full lifecycle of management systems (Trackwise), ensuring alignment with operational needs and technological innovation. This role requires balancing technical expertise with strategic vision to optimize processes and maintain system integrity. Key Responsibilities • Design, configure, test, deploy, maintain, and improve applications. • Collaborate closely with QA, IT, and business stakeholders to define system requirements and solutions. • Orchestrate clear, efficient, and well-documented configurations and scripts, following best practices and compliance standards. • Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP, 21 CFR Part 11), and data integrity. • Troubleshoot, debug, and upgrade existing systems to ensure optimal operations and minimal downtime. • Contribute to the full system lifecycle, from requirements gathering and design through deployment, training, and ongoing support. • Stay updated with emerging technologies and apply relevant advancements to improve system functionality. • Work closely with QA and compliance teams to ensure that applications meet the highest quality and regulatory standards. • Assist in project planning, task estimation, and risk identification, proactively addressing potential issues and proposing effective solutions. • Provide ongoing support, training, and mentorship to users and administrators. Key Requirements • Minimum of 3-5 years of experience in IT Systems operations, with a focus on regulatory and Quality Solutions. • Trackwise experience is required. • Proven experience with Regulatory & Quality Systems. • Proficient in system configuration, SLA Management and business stakeholder management. • Strong understanding of data management and regulatory requirements (e.g., GxP, 21 CFR Part 11). • Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices. • Familiarity with database technologies (e.g., SQL) and web services (e.g., REST, SOAP). • Experience with version control systems (e.g., GitHub) and change management processes. • Excellent problem-solving and analytical skills, with attention to detail and data integrity. • Strong communication and teamwork abilities, with experience collaborating across functional teams. • Experience with cloud services and technologies is a plus. • Ability to lead training sessions and support end-users in a regulated environment. Education/ Qualifications • A Masters / Bachelors degree in business, information technology, or a related field. Advanced degrees or certifications are a plus. • Itil 4, Prince 2 or GMP is a plus Travel Requirements • Position involves travel up to 10% of the time, mostly within Europe, Asia Pacific, and the Americas. Most trips will include overnight travel. Languages • English • Spanish or Portuguese is a plus Working conditions • Remote working model