Senior Technology Quality Assurance Auditor

1 month ago

Southeast Fairbanks, United States Parexel Full time

Home Based, US

As a Senior Technology Quality Auditor (TQA) you will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of internal and supplier technology audits. You will exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically. The TQA Senior Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards.


Technology Quality auditors possess significant authority and decision-making power within clinical trials. They autonomously assess technology, data integrity practices, and regulatory compliance, recommending necessary changes to ensure adherence to standards when deviations or non-compliance are identified. Technology Quality auditors also provide guidance on best practices and address compliance issues through discussions with sponsors, investigators, and stakeholders.

Accountabilities:

Lead, perform and report auditsManage Technology auditsLead and coordinate internal audit programs (global and regional)Support Serious BreachesSupport auditor training and MentoringMaintain QA records / systemsSupport Sponsor Audits and Regulatory InspectionsMaintain sound knowledge of Parexel policies, procedures, and guidelines and promote compliance within ParexelBuild, develop, and maintain working relationships with internal and external customer groups ​ Skills:Excellent interpersonal, verbal and written communication skillsAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailExperience with Microsoft based applications and ability to learn internal and supplier computer systemsWillingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamworkAbility to develop relationships with culturally diverse stakeholders, including Parexel team members and sponsor representativesAbility to work professionally with highly confidential informationFlexibility and ability to adjust to changing priorities and unforeseen eventsExcellent time management skills and the ability to follow-up on multiple tasks and projectsAbility to diplomatically address sensitive issues confidentially and professionallyAbility to work consistently in a fast-paced environmentKnowledge and Experience: Strong knowledge of GxP, industry standards, applicable international technology compliance regulations Must be detail oriented and able to maintain a 'big picture' overview during a sponsor audit or inspection Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically Familiar in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems Education:Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience Five to nine years of experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support
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