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Quality Manager, Project Quality and Risk Management

Parexel International Corporation

USA - Southeast - Home Based

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

As a Quality Manager, you will partner with Global Data Management/Clinical Database Programming or Biostatistics/Statistical Programming teams focusing on investigating and analyzing first-time quality, robust risk and issue management and supporting an inspection-ready state. You will provide Quality expertise on Clinical Trials, trough the execution of Quality SOP's to support operations, leadership, clients and patients.

Key Accountabilities: Work with quality & operational management to identify, analyze, report and advise on areas of risks on projectsProvide transparency to compliance with quality expectations to operational management (via metrics, reports, meeting attended/chaired) Lead project teams to investigate more complex issues and root causes Facilitate development of robust CAPA for more complex issues Contribute to critical issue resolution by providing expert quality advice & direction - serve as eQMS SME Review SOP deviations considering client & Parexel processes, regulatory requirements and guidance Support assessment of potential Serious Breach of GCP & developing containment actions Support audit/inspection preparation including helping teams set priorities, reviewing key documents and responses Establish * maintain strong partnerships with operational management - other quality business units and line managers to ensure continuous improvement & regulatory complianceDeputize for the Head of Data Services, Project Quality Risk Management as assigned, representing specific topicsQualificationsSkills: Able 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.Expert analytical critical thinker, able to focus on identifying potential and real issues, investigating root causes, brainstorming, imagining alternatives and assessing the effectiveness of actionsExpert skills 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 knowledgeAbility to effectively mentor less experienced members of staff.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. Master’s degree in a science, technology or industry related discipline, preferred.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: 2021-07-09

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