Sr. Audit Specialist

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.

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. They have the authority and decision-making responsibility to drive Parexel departments’ and Project teams’ Sponsor Audit and Regulatory Inspection preparation activities. 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.

Liaise with the Sponsor and Parexel project team, Quality Assurance Management and staff, other Quality departments throughout the lifecycle of an SAI
- Conduct 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, tomanage an SAI effectively and seamlessly
- Ensure SAIs are performed to a high degree of client satisfaction and regulatory requirement
- Build, develop, and maintain good working relationships with internal and external customer groups
- Determine most appropriate setting to host an SAI, based upon requirements
- Actively support the host throughout aSAI , as applicable
- Support Non-Parexel-facility audits and inspections, e.g. investigator sites, supplier sites, investigator sites, 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
- Summarize quality events arising from sponsor audits and other related activities, as requested.
- Enter SAI information into the Parexel eQMS and provide follow up on outcomes, as needed.
- With First Time Quality – ensure that information is added and relayed effectively and correctly