When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Durham, NC (Hybrid Role) The Sr Audit Specialist will have the experience and knowledge to provide guidance and facilitate the effective preparation, management and follow up of Sponsor Audits and Regulatory Inspections. 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. End-to-End Facilitation of Sponsor Audits Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, throughout the lifecycle of an Audit Conduct all preparation meetings, assign tasks with other internal departments 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 seamlessly -Ensure audits are performed to a high degree of client satisfaction -Build, develop, and maintain good working relationships with internal and external customer groups Determine most appropriate setting to host an audit, based upon sponsor audit requirements Actively support audit host throughout a sponsor audit onsite (where applicable) Support Non-Parexel-facility audits, e.g. supplier sites, internal audits at sponsor offices, as applicable Ensure that Technical Enterprise Tools e.g., extranet, PMED, PMEX and Microsoft Teams are set up correctly, are tested and tailored to the Sponsors specific requirements Support the maintenance of SAIG Tools Summarize 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 correctly Development / Review of Procedures Create or contribute to Lessons Learned after any audit activity hosted, to ensure continuous quality improvement Proactively 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 Awareness Maintain 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 applicable Promote compliance within the company and represent QA, as required Proactively re/review QA SOPs and be able to speak to their contents Develop and maintain network contacts with other Quality Assurance professionals Support regulatory inspections as needed Build and Maintain Relationships Build, develop, and maintain good working relationships with internal and external customer groups. Work well in team environment. Travel on assignments as required. Travel time could be up to 20%. Education Educated to the degree level (BS, BA) or equivalent experience EEO Disclaimer Parexel 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. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.