Quality - Audit & Inspection, Senior Specialist (Contract) 29582

Job Description

The Audit and Inspection Management (AIM) Audit Management Senior Specialist provides operational, administrative, and process support to the Audit and Inspection Management team across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practice (GLP) activities. This role serves as a key business partner supporting audit execution, record management, corrective and preventive action (CAPA) tracking, stakeholder communication, and continuous process improvement initiatives.This individual will collaborate with cross-functional and external stakeholders to facilitate audit planning, maintain audit-related records and documentation, and assist in ensuring the timely progression and closure of audit and inspection deliverables.

 

KEY RESPONSABILITIES

 

Audit and Inspection Operations Support

• Support the planning, coordination, and scheduling of GCP, GVP, and GLP, audits.
• Coordinate with internal and external stakeholders to facilitate audit logistics, meeting scheduling, and audit communications
• Draft and distribute audit notifications, agenda communications, and audit-related correspondence.
• Assist with the collection and organization of pre-audit documentation and investigator site audit requests from the electronic Trial Master File (eTMF) and other applicable systems.
• Support audit teams before, during, and after audits to ensure efficient execution of audit activities.

CAPA and Quality Record Management

• Support the management and progression of audit, and inspection observation and CAPA records within the applicable quality management system.
• Review CAPA evidence packages for completeness and adherence to submission requirements prior to formal quality review.
• Assist in evaluating submitted evidence against established requirements and escalate questions or concerns as appropriate to audit owner.
• Enter, upload, and maintain CAPA documentation and supporting evidence within document management system.
• Monitor due dates and milestones for records and CAPAs and proactively follow up with responsible stakeholders regarding upcoming or overdue activities.
• Support record lifecycle management activities, including updates, amendments, and administrative modifications within data management system as needed.
• Generate reports and provide status updates regarding audit ownership, and CAPA progress.

Meeting and Communication Management

 

•  Lead coordination of recurring team meetings, including weekly, bi-weekly, and ad hoc meetings.
• Collect agenda topics from team members and stakeholders.
• Prepare meeting agendas and supporting materials.
• Facilitate meeting logistics and attendance coordination.
• Record meeting minutes, action items, decisions, and follow-up activities.
• Distribute meeting minutes and track action item completion.
•  Support communication activities across the Audit and Inspection Management team.

 

Stakeholder and Change Management Support

• Participate in and support cross-functional meetings related to projects, system implementations, process improvements, and change management activities.
• Gather team feedback regarding process enhancements, system improvements, tools, templates, and team resources.
• Support implementation and communication of process and system updates affecting audit and inspection activities.
• Serve as a point of contact for administrative and operational questions related to audit management processes.

 

SharePoint, Tools, and Knowledge Management

 

• Maintain and organize team SharePoint sites, document repositories, folders, tools, templates, and reference materials.
• Conduct periodic reviews and cleanup activities to ensure information remains current, organized, and accessible.
• Coordinate updates to audit tools, templates, trackers, and supporting documentation.
• Collect and consolidate recommendations for process and template improvements.

Audit Program Development and Learning Opportunities

• Support the development, revision, and maintenance of audit questionnaires and assessment tools.
• Assist with questionnaire-based audit activities and assessments.
• Participate in audit planning and execution activities as a developmental opportunity.
• Support continuous improvement initiatives within the Audit and Inspection Management function.

QUALIFICATIONS

Education and Experience- Bachelor's degree in Life Sciences, Quality, Business A