Data Governance Quality Manager

Office Based Durham, NC or Home Based with travel to Durham, NC within 2 hours The Quality Manager provides support and advice to Operational groups in the Real World Evidence (RWE) / Real World Data space (RWD) on the application of, and adherence to processes and the use of systems. Supports Data Governance Quality Oversight (DGQO) and Operations staff at audits, client assessments or regulatory inspections, as needed. Researches and advises on relevant regulatory and industry trends and initiatives to ensure company stays current on compliance issues. Facilitate reporting, handling and follow up of Quality Issues. Works closely with Operations management and with Line Manager to ensure continuous process improvement. Represents DGQO at audits, inspections and client assessments, including preparation, conduct and follow up. Where assigned, work with Operational groups to provide expert review of client-defined processes/quality and/or training materials. Investigate internal quality issues, and provide suggestions for process improvements to the appropriate Operations team and Operations QM management. Monitor until resolution. Monitors and reports on audit responses, providing metrics as appropriate. Supports staff in use of automated quality systems. Confirms close-out of assessment findings, remediation of Quality Assurance audit and regulatory inspection findings in accordance with stated response times. Reviews the results of operational QC processes. Initiates escalation of significant quality events to the Head of DGQO and the responsible Line Manager. Using process mapping and analysis techniques identify areas for efficiency gains and process improvements within Operations and Quality groups, with subsequent development and implementation of action plans. Working with the Technical QM group, assess technology that may include the evaluation of appropriate systems/software to increase quality and productivity. Supports Corporate programs related to either RWE/RWD and/or Data Governance/Data Integrity at PARE QualificationsExperience in one or more areas of Real World Data / Real World Evidence or general Data Governance is preferred. Candidates with an analytical background will be considered.Significant experience in a Quality role is preferred.Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience required.Education: Bachelor’s degree or equivalent experience, preferably in scientific, business or other analytical fieldEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.