Senior Audit Specialist

Home Based, US

The Senior Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of complex Sponsor Audits and Regulatory Inspections. Will exhibit a high degree of flexibility and initiative, make decisions during audits in line with Parexel’s QMS, demonstrate the ability to follow up on multiple tasks and projects, and ensure that audits and inspections are hosted with a high degree of expertise and quality.

End-to-End Facilitation of Sponsor AuditsLiaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, other Quality departments throughout the lifecycle of an AuditConduct all preparation meetings, assign tasks with other internal departments, review all material to be presented and gather necessary information on Sponsor confidentiality agreement documentation.Initiate planning process(es), e.g., project plans with deadlines and milestones, to administer an audit effectively and seamlesslyEnsure audits are performed to a high degree of client satisfactionBuild, develop, and maintain good working relationships with internal and external customer groupsDetermine most appropriate setting to host an audit, based upon sponsor audit requirementsActively support audit host throughout a sponsor audit onsite (where applicable)Support Non-Parexel-facility audits, e.g. supplier offices, sites, internal audits at sponsor offices, as applicableEnsure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirementsSupport the maintenance of SAIG ToolsSummarize quality issues arising from sponsor audits and other related activities, as requested.Enter Sponsor audit information into the Parexel audit module of eQMS and provide follow up on outcomes, as needed.With First Time Quality – ensure that information is added and relayed effectively and correctlyContribute to the SAIG framework and local tools as applicableDevelopment / Review of ProceduresCreate or contribute to Lessons Learned after any audit activity hosted, to ensure feedback is provided with the aim of continuous quality improvementProactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate.Ability to review and offer feedback of associated standard operating procedures, from a QA perspective.Maintain GXP and Regulatory AwarenessMaintain relevant knowledge of appropriate GxP requirements and developments as they impact Parexel’s international SOPs and compliance with GxP. Communicate to QA team and management, as applicablePromote compliance within the Company and represent QA, as requiredProactively re/review QA SOPs and be able to speak to their contentsDevelop and maintain network contacts with other Quality Assurance professionalsSupport regulatory inspections as neededBuild and Maintain RelationshipsBuild, develop, and maintain good working relationships with internal and external customer groups.Work well in team environment.Perform other quality related tasks or projects as assignedPerform other quality related tasks or duties as assigned.Travel on assignments as required. Travel time could be up to 20%.QualificationsSkills:Ability to confidently and diplomatically address sensitive issues professionallyExcellent interpersonal, verbal and written communication skillsAbility to manage multiple and varied tasks with enthusiasm and prioritize workload withattention to detailExperience with Microsoft based applications and ability to learn internal 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 or escalate sensitive issues confidentially and professionallyA team player with a positive attitudeAbility to work consistently in a fast-paced environmentKnowledge and Experience:Significant experience in Quality Assurance, auditing, relevant Quality Management and clinical trial support (at least 5 years)Strong knowledge of GxP, industry standards, applicable regional regulationsMust be detail oriented and able to maintain a ‘big picture’ overview during a sponsor audit or inspectionAbility to follow up on multiple tasks and projects, and to handle confidential information diplomaticallyEducation:Educated to degree level (technology, biological science, pharmacy or other health relateddiscipline preferred) or equivalent qualification or clinical research experienceStrong command of written and spoken English language, local language proficiency asrequired