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
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Support the planning, coordination, and scheduling of GCP, GVP, and GLP, audits.
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Coordinate with internal and external stakeholders to facilitate audit logistics, meeting scheduling, and audit communications
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Draft and distribute audit notifications, agenda communications, and audit-related correspondence.
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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.
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Support audit teams before, during, and after audits to ensure efficient execution of audit activities.
CAPA and Quality Record Management
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Support the management and progression of audit, and inspection observation and CAPA records within the applicable quality management system.
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Review CAPA evidence packages for completeness and adherence to submission requirements prior to formal quality review.
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Assist in evaluating submitted evidence against established requirements and escalate questions or concerns as appropriate to audit owner.
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Enter, upload, and maintain CAPA documentation and supporting evidence within document management system.
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Monitor due dates and milestones for records and CAPAs and proactively follow up with responsible stakeholders regarding upcoming or overdue activities.
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Support record lifecycle management activities, including updates, amendments, and administrative modifications within data management system as needed.
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Generate reports and provide status updates regarding audit ownership, and CAPA progress.
Meeting and Communication Management
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Lead coordination of recurring team meetings, including weekly, bi-weekly, and ad hoc meetings.
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Collect agenda topics from team members and stakeholders.
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Prepare meeting agendas and supporting materials.
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Facilitate meeting logistics and attendance coordination.
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Record meeting minutes, action items, decisions, and follow-up activities.
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Distribute meeting minutes and track action item completion.
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Support communication activities across the Audit and Inspection Management team.
Stakeholder and Change Management Support
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Participate in and support cross-functional meetings related to projects, system implementations, process improvements, and change management activities.
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Gather team feedback regarding process enhancements, system improvements, tools, templates, and team resources.
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Support implementation and communication of process and system updates affecting audit and inspection activities.
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Serve as a point of contact for administrative and operational questions related to audit management processes.
SharePoint, Tools, and Knowledge Management
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Maintain and organize team SharePoint sites, document repositories, folders, tools, templates, and reference materials.
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Conduct periodic reviews and cleanup activities to ensure information remains current, organized, and accessible.
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Coordinate updates to audit tools, templates, trackers, and supporting documentation.
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Collect and consolidate recommendations for process and template improvements.
Audit Program Development and Learning Opportunities
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Support the development, revision, and maintenance of audit questionnaires and assessment tools.
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Assist with questionnaire-based audit activities and assessments.
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Participate in audit planning and execution activities as a developmental opportunity.
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Support continuous improvement initiatives within the Audit and Inspection Management function.
QUALIFICATIONS
Education and Experience
- Bachelor's degree in Life Sciences, Quality, Business Administration, Healthcare, or related discipline preferred.
- Experience supporting quality, compliance, audit, inspection, clinical research, pharmacovigilance, laboratory, or regulated industry activities preferred.
- Experience working with quality management systems, document management systems, electronic trial master files (eTMF), SharePoint, and Microsoft Office applications preferred.
Knowledge and Skills
- Strong organizational and project coordination skills.
- Excellent written and verbal communication skills.
- Ability to manage multiple priorities and deadlines simultaneously.
- Strong attention to detail and documentation management capabilities.
- Ability to work effectively with cross-functional stakeholders across multiple levels of the organization.
- Experience preparing meeting agendas, minutes, reports, and communications.
- Ability to maintain confidentiality and handle sensitive quality and compliance information appropriately.
- Strong problem-solving and continuous improvement mindset.
- Working knowledge of GCP, GVP, GLP, and quality management principles.
Key Competencies
- Organization and Planning
- Communication and Collaboration
- Stakeholder Management
- Quality and Compliance Focus
- Attention to Detail
- Record and Documentation Management
- Process Improvement
- Accountability and Follow-through
- Customer Service Orientation
- Adaptability and Change Management
Pay Range:
$55-$60/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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