Location : 100% remote, may be required to be on-site 1 day a month for meetings in NJ Duration : 6+ Month Must have experience with Quality Systems and Quality Processes Data Integrity Specialist Supervises the creation of Data Integrity risk assessments and risk mitigation activities Ensures Data Integrity activities are completed on time Ensures compliance with global Data Integrity regulatory requirements (ie. GXP, 21 CFR Part 11, WHO, MHRA) Plays operation role in data integrity assessments and development of action plans to address deficiencies if required Ensures compliance with established Data integrity processes and tools through periodic review. Helps identify the source of the compliance issue and provides recommendations on resolution Provides updates to the Data Integrity office leadership, mentoring, and coaching for testing & Validation team members (Managed Service Partner) to achieve strong regulatory results, as well as quality results Collaborate with project managers and business teams for all projects involving Data Integrity activities. Oversees and provides guidance to project managers and other resources engaged with Data Integrity. Reviews and provides comments on project-related documents. Review and approve all Data Integrity deliverables for their accuracy and quality and bring them to leadership’s attention as required Talking full responsibility for all Data Integrity artifices. Publish all SLA and another performance matrix of DI Office minimally every quarter or on a demand basis Provides Data Integrity support to requests related to regulatory inspections. Helps to define the Data Integrity priorities for customers (IT and other functional areas) Knowledge - Strong understanding of Global regulations from FDA, EMEA