Open to opportunities

Jennifer Lail

@jenniferlail

Message

Clinical quality systems specialist and document control expert with 8+ years in GxP-regulated environments.

United States

Message

What I'm looking for

I seek a senior-quality or document control role in a GxP-regulated organization where I can lead QA documentation programs, improve processes, mentor teams, and support audit readiness.

I am a Clinical Quality Systems Specialist and Document Control professional with over eight years of experience managing GxP-regulated documentation across pharmaceutical, medical device, and CRO environments.

I have administered 12,000+ controlled documents as an expert Veeva Vault QualityDocs administrator, supported 75+ sponsor audits and regulatory inspections, and led SOP lifecycle, change control, CAPA, and deviation tracking initiatives to maintain inspection-ready documentation.

My work includes designing and implementing formal QA programs, reducing review cycle times, standardizing deliverable quality, and executing large-scale document consolidations and migrations following corporate acquisitions.

I am PMP-certified with a Master's in Education (Training & Development), and I design and deliver training, onboarding, and compliance workshops to improve cross-functional adherence, accessibility, and knowledge management.

Experience

Work history, roles, and key accomplishments

Quality Specialist

Guardians of Honor

Jan 2023 - Jan 2025 (2 years)

Designed and implemented a formal Quality Assurance program for NASA's Next Gen STEM initiative, achieving zero compliance findings and standardizing SOP-driven workflows across deliverables.

Quality Assurance Document Control SOP Lifecycle Management Veeva Vault Smartsheet Knowledge Management

Process Analyst - Lead QMS

ICON plc

Jan 2020 - Jan 2023 (3 years)

Managed lifecycle of 12,000+ controlled documents in Veeva Vault, supported 75+ sponsor audits, led document consolidation post-acquisition, and executed CAPA to improve QMS compliance.

Veeva Vault Document Management Change Control CAPA Audit Support UAT Training Development

Senior LMS Analyst

PRA Health Sciences

Jan 2017 - Jan 2020 (3 years)

Administered LMS inventory of 600+ SOPs and managed training assignments and periodic reviews to ensure GxP compliance, while designing onboarding and compliance training content.

Learning Management Systems SOP Management Training Development Compliance Reporting GxP Curriculum Design