Hillary Driscoll
Senior IT Quality and Compliance Leader
- Role
- IT Quality Industry Lead - Validation at Compliance Group Inc
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Hillary Driscoll
I am an IT quality and compliance professional with over 27 years of experience working in a regulated environment (GxP, Data Privacy), in the biotech/pharma industry with knowledge of FDA, MHRA, Annex 11, GAMP5, EMA, ICH regulations and guidelines.My experience includes: Head of IT Quality Management/Validation team11+ years of line managementOrganizational change managementCommunication planning and stakeholder analysisProcess design and improvementMeasurement and analysis of process efficacy SOP and work instruction authoringDesigning, developing, and conducting training for IT systems & procedures/SOPsComputer System Validation (CSV) including eliciting and authoring requirements, validation testing, and UAT using waterfall, iterative, and agile methodologiesAudit and inspection support including CAPA managementApplication support and troubleshootingClinical Data Management
Experience
IT Quality Industry Lead - Validation
Oct 2025 — Present
Education
MIT Professional Education
Applied Agentic AI for Organizational Transformation
Virginia Tech
BS, Biology
1994 — 1998
Skills
- Change Control
- Informatics
- Quality Assurance
- Software Documentation
- Cross-Functional Team Leadership
- Sdlc
- Pharmaceutical Industry
- Clinical Trials
- Data Analysis
- Process Improvement
- Business Analysis
- Management
- Requirements Analysis
- CRO
- Computer System Validation
- Business Process Improvement
- Databases
- Requirements Gathering
- Project Management
- Software Development Life Cycle (Sdlc)
- Business Requirements
- Integration
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