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