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Quality Manager

Parexel International Corporation

Durham, North Carolina

The Quality Manager's role is to oversee and ensure that robust processes are in place with respect to Data Governance, constantly evaluating and overseeing process development.Provide consultancy to Parexel teams with respect to the wider Quality Management System (QMS) as well as any relevant processes regarding Data Governance.Ensure that audits (both internal Quality Assurance and external Sponsor) and regulatory inspections are supported as needed from the DGQO group, and that findings are responded to well and in a timely manner.Ensure that Quality Issues pertaining to Data Governance are investigated (i.e. root cause analysis) and resolved (via completed Corrective and/or Preventive Actions), tracked and reported to senior management.Ensure that the reporting and trending of Quality Issue, Audit findings and other relevant data is performed with respect to Data Governance aspects.Maintains a familiarity with Parexel QMS-related applications and related processes.Participates in projects and initiatives as assigned, including reporting information and escalations as needed.Maintains a positive, results orientated work environment, building partnerships and modeling teamwork, communicatingIdentification of process gaps and/or improvement opportunities.Report process gaps and participate in implementation of process improvement.Work closely with Operational management and with Line Manager to ensure continuous process improvement, as assigned.QualificationsSkills:

Experience with enterprise data governance within a CRO or related industryExperience with change management and/or Six Sigma methodologySignificant experience in a Quality/Regulatory/Quality Assurance role, preferably in a Data settingExperience/understanding of Computer Systems Validation principlesMinimum of 3 years’ experience in a Quality/Regulatory/Quality Assurance role, preferably in a Data settingEducation:

• Bachelor’s degree or equivalent experience, preferably in scientific, business or other analytical field

EEO 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.

Job posted: 2020-06-12

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