Solution Owner Quality Management System (regulatory & Quality)

ConvaTec Group

Fully remote
Trackwise system experience required
Regulatory compliance gxp and 21 cfr part 11
System configuration and validation practices
ConvaTec Group is seeking a Solution Owner for their Quality Management System with a focus on regulatory and quality solutions. The role requires managing the lifecycle of systems like Trackwise, ensuring compliance with industry standards while collaborating with various stakeholders

Job Summary

  • This role oversees the full lifecycle of management systems to ensure alignment with operational needs and technological innovation within a global medical products company.
  • The position requires balancing technical expertise with strategic vision to optimize processes while maintaining strict system integrity and regulatory compliance standards.
  • Candidates will collaborate closely with QA, IT, and business stakeholders to define requirements, validate systems, and provide ongoing support in a highly regulated environment.

Matching Summary

Match Score: 85

ConvaTec Group is seeking a Solution Owner for their Quality Management System with a focus on regulatory and quality solutions. The role requires managing the lifecycle of systems like Trackwise, ensuring compliance with industry standards while collaborating with various stakeholders.

Skills & Requirements

Must-have

  • Trackwise system experience required
  • Regulatory compliance GxP and 21 CFR Part 11
  • System configuration and validation practices
  • IT systems operations in regulated environment
  • SQL database and web services knowledge

Nice-to-have

  • Cloud services and technologies familiarity
  • Agile and Scrum methodology experience
  • Spanish or Portuguese language skills
  • Mentorship and training delivery abilities
  • Version control with GitHub proficiency

Key Requirements

  • 3-5 years experience in IT Systems operations
  • Bachelor's or Master's degree in IT or related field
  • Proven Trackwise experience mandatory
  • Strong understanding of data integrity regulations

Work Rights

Not specified

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