Sr Quality Specialist, Project Quality and Risk Management

Home Based or Office Based, North Carolina (need to be within driving distance to Durham, NC)

As a Sr Quality Specialist with Parexel you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. You will provide quality expertise through the execution of quality SOP's to support operations, leadership and clients.

Key Accountabilities:

You will manage the relationship with Operations, with limited Line Manager or experienced data services PQRM assistance. Assist with establishing & maintaining a strong partnership with operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance Provide transparency to compliance with quality expectations to operational management (via metrics, reports, meeting attended/chaired) Champion the Quality Management System within both the group and the Operational teams via Operational management Provide input to Quality forums, to facilitate meaningful discussion that leads to action on key risk areas Contribute to initiatives to accomplish PQRM's goals Provide Quality input to audits/inspections with limited Line Manager support or Data Services assistanceSupport audit/inspection preparation including helping team set priorities and reviewing key documentsProvide onsite (office) or remote support as neededLead project team to investigate root causesFacilitate development of robust CAPAContribute to critical issue resolution by providing expert quality advice and directionServe as an eQMS SMEProvide quality consultancy as assignedRespond to consultancy requests to enable project teams to deliver first-time qualityReview and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirementsConsult SMEs including other quality experts when necessary to resolve issuesFacilitate identification and remediation of Quality Issues (QIs) as assignedEnsure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classification, as assignedSupport initial assessment of Serious Breach of GCP developing containment issuesEscalate issues to leadership as necessaryDevelop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance with limited Line Manager assistance.

Facilitate the Risk Evaluation process.

Maintain compliance with Parexel standards and regulatory requirements

QualificationsSkills: Emerging ability to lead without explicit authority Self-management: independent, takes initiative, proactive & organized Focused on quality results - attention to detail and first time quality Persistent - does not give up! Sees the big picture & understands how the pieces fit together Excellent interpersonal, verbal and written communication skills.Growing skills as an analytical critical thinker, able to focus on identifying potential and real issues, investigating root causes, brainstorming, imagining alternatives and assessing the effectiveness of actionsSkilled in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identity areas of risk, trends and aggregate issuesAbility to plan, organize others, prioritize and manage workload independentlyAdaptable to changing environments, able tot think quickly, able to deal with ambiguity and learn new tasks applying routine knowledgeCultural awareness with the ability to thin and work, globally Able to travel as needed for the position Knowledge and Experience:Experience in a Quality/Regulatory/Quality Assurance role following GCP/ICH E8Experience in one or more areas of Data Management, Biostatistics, Programming and/or Medical Writing.Significant experience is required in either a functional area or Quality but ideally, both Understanding of clinical technology solutions is preferredEducation: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.