The Regulatory and Quality Compliance (RQC) team is responsible for assuring that TraceLink products and services are compliant with relevant global regulations for the life sciences industry, including but not limited to GxP, 21 CFR Part 11, Annex 11, GAMP5, and TraceLink policies and standards. Our customers consider compliance with such industry regulations to be mandatory, and this is confirmed through frequent audits conducted by customers.
Become a part of the RQC team to ensure compliance with the TraceLink quality management system, relevant global regulations, and TraceLink corporate policies regarding Development, IT, Customer Support and Service delivery. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Report non-compliance issues and/or identified risks to TraceLink senior management and, where applicable, TraceLink information security, legal/privacy, etc.
Summary of Position
Skills and Experience