Quality Manager, Data Services Project Quality and Risk Management

Home Based, Southeast Region

As Quality Manager, Data Services, Project Quality & Risk Management you will partner with operational teams focusing first-time quality, robust risk and issue management and maintaining an inspection-ready state. You will provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.

Key Accountabilities:Establish & maintain strong partnerships with operational management - Director level, other quality business units and line managers to ensure continuous improvement & regulatory complianceDeputize for the Head of Data Services as assigned, representing specific topicsProvide transparency to compliance with quality expectations to operational management (via metrics, reports, meeting attended/chaired)Support audit/inspection preparation including helping teams set priorities and reviewing key documentsLeads project team to investigate more complex issues and root causesFacilitate development of robust CAPA for more complex issuesReview audit/inspection responses prior to final QA review Contribute to critical issue resolution by providing expert quality advice & direction - serve as eQMS SMEReview and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirementsEnsure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classificationSupporting initial assessment of Serious Breach of GCP & developing containment actionsWork with quality and operational management to identify risk areasQualificationsSkillsAbility to lead without explicit authoritySelf-management: independent, takes initiative, proactive and organizedFocused on quality results - attention to detail and First Time QualityPersistent – doesn’t give up!Curious - asks questions, investigates issuesBuild relationships through collaboration, stays positiveClient-focused - able to get to and interpret the needSees the big picture - how the pieces fit togetherSecure interpersonal, verbal and written communication skills Expert analytical critical thinker, focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actionsAbility to develop professional, collaborative relationships both within Quality and with OperationsExpert skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issuesAdaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledgeAbility to plan, organize others, prioritize and manage workload independentlyQuality oriented with an attention to detail, taking initiative, ownership and accountability for deliverablesAbility to manage the complexity of a matrix environment while valuing the importance of teamworkCultural awareness with the ability to think and work, globallyAbility to provide direction and mentoring to less experienced staffAbility to travel as needed for the positionKnowledge and Experience:Experience in one or more areas of Data Services QM (e.g. process validation) or the functional areas that Data Services QM support.Understanding of Clinical technology solutions is preferred.Significant experience in a Quality/Regulatory/Quality Assurance/Training role.Education:Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experienceMaster’s degree in a science, technology or industry related discipline, preferredEEO 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.