Quality & Regulatory Specialist at SofMedica ensuring compliance with quality standards and managing quality management systems. Overseeing supplier qualifications and participating in audits.
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Hybrid Solution Owner, Quality Management System – Regulatory & Quality
Posted 10 hours ago
About the role
- Solution Owner overseeing Trackwise systems for regulatory and quality solutions at Convatec. Balancing technical expertise with strategic vision to optimize processes and maintain system integrity.
Responsibilities
- Oversees the full lifecycle of management systems (Trackwise), ensuring alignment with operational needs and technological innovation.
- 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.
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.
Benefits
- Health insurance
- Retirement plans
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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