Solution Owner – Quality Management System, Regulatory & Quality

This is a fully remote position, open to applicants in India.

📋 Description

• Manage the complete lifecycle of TrackWise quality management systems, ensuring alignment with operational requirements and technological advancements.

• Design, configure, test, deploy, maintain, and enhance applications.

• Collaborate with QA, IT, and business stakeholders to establish system requirements and solutions.

• Develop clear, efficient, and well-documented configurations and scripts, adhering to best practices and compliance standards.

• Engage in system reviews and validation activities.

• Diagnose, troubleshoot, and upgrade existing systems.

• Contribute throughout the entire system lifecycle, from requirements gathering and design to deployment, training, and ongoing support.

• Leverage emerging technologies to enhance system functionality.

• Ensure applications comply with quality and regulatory standards in partnership with QA and compliance teams.

• Assist in project planning, task estimation, and risk assessment.

• Offer continuous support, training, and mentorship to users and administrators.

⛳️ Requirements

• At least 5 years of experience in IT systems operations with a focus on Regulatory and Quality Solutions.

• Required experience with TrackWise.

• Experience in managing TrackWise version upgrades and customizations is a plus.

• Demonstrated expertise in Regulatory & Quality Systems.

• Proficient in system configuration, SLA management, and managing business stakeholders.

• Strong knowledge of data management and regulatory requirements, including GxP and 21 CFR Part 11.

• Familiarity with Agile, Scrum, and system validation methodologies.

• Knowledge of SQL and web services such as REST and SOAP.

• Experience with version control systems like GitHub and change management processes.

• Exceptional problem-solving and analytical abilities, with a keen attention to detail and data integrity.

• Strong communication and collaboration skills across various functional teams.

• Experience with cloud services and technologies is advantageous.

• Capability to lead training sessions and assist end-users in a regulated environment.

• A Master’s or Bachelor’s degree in IT or a related discipline.

• ITIL 4, Prince2, or GMP certification is a plus.

• Relevant certifications are desirable.

• Willingness to support UK/EU time zones.

🏝️ Benefits

• Comprehensive training and mentorship for users and administrators.

• A supportive and empowering work environment.

• Equal employment opportunities.

• Opportunity to impact solutions that enhance patient outcomes and lower care costs.