Project Quality Lead I

Verify compliance with GxP guidelines/regulations, Parexel procedures and requirements, and sponsor requirements. Actively participate in key internal project team meetings and facilitate quality discussions during these meetings. Schedule and lead the project related Quality Forums. Attend client meetings with project team leadership to collaborate with and participate in discussions related to quality. Provide quality advice to the project teams. Participate in relevant project team training. Provide support with investigation of Quality Issues (QIs) and support of QI management including classification of issues, assist in determination of root cause and consultation on appropriateness of corrective and preventive actions. Provide audit and inspection support for assigned projects, including, where feasible, advising the project team during preparation and conduct of audits and inspections as per applicable SOPs. Review and provide feedback on project related audit/inspection responses generated by project team members per applicable SOPs. Represent Quality Management in audits and inspections as required. Evaluate the quality status of a project by reviewing applicable project quality metrics. Identify and evaluate potential risks and quality issues in collaboration with project team leadership and other relevant parties (e.g., Project Management Quality Management, operational and functional staff). Together with these parties, determine appropriate mitigation measures. Collaborate with other PQRLs assigned to the client to identify quality trends, program-wide corrective and preventive actions, and act as primary point of contact for communications with client quality representatives, share lessons learned. Report process gaps and participate in implementation of process improvement when required. Participate in working groups as assigned to develop SOP and/or quality related processes. Maintain compliance with training curriculum. Consult process SMEs as necessary for guidance. Share lessons learned across Project Quality & Risk Management group and/or projects. Supporting audits and inspections as host/co-host/other support, as assigned. QualificationsGood interpersonal, verbal, and written communication skills. Client focused approach. Ability to act as the main quality contact with clients. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with good organizational skills. Detail oriented. Ability to work effectively in a matrix environment and to demonstrate and foster teamwork. IT literate: experienced with Microsoft based applications and general knowledge of personal computer functions. Relevant experience (e.g., in the pharmaceutical or CRO industry). English proficiency (written and oral English) Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience. 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.