Solution Owner Quality Management System
SKILLS
FULL DESCRIPTION
Solution Owner Quality Management System
[Employer hidden — sign up to reveal] is seeking a Solution Owner for their Quality Management System (Regulatory & Quality). This is a remote, full-time, mid-senior level position.
About [Employer hidden — sign up to reveal]
[Employer hidden — sign up to reveal] is a global medical products and technologies company, focused on solutions for the management of chronic conditions. With more than 10,000 colleagues, we provide our products and services in around 90 countries. [Employer hidden — sign up to reveal]'s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com.
Position Overview
The Solution Owner Quality Management System (Regulatory & Quality) oversees the full lifecycle of management systems (Trackwise), ensuring alignment with operational needs and technological innovation.
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 / Bachelor's 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 required. Spanish or Portuguese is a plus.
Working Conditions
Remote working model.
Equal Opportunities
[Employer hidden — sign up to reveal] provides equal employment opportunities for all. For inquiries, contact [Employer hidden — sign up to reveal].
Notice to Agencies
[Employer hidden — sign up to reveal] is not accepting unsolicited resumes from agencies.