Carrie McCann
Experienced GxP Computerized System Validation/Computer Software Assurance (CSV/CSA) Professional | Software Quality, Regulatory, and Compliance Leader | Certified Scrum Master
- Role
- Senior Manager of IT Operations (Validation, Quality, and Compliance) at ICON plc
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Carrie McCann
With a robust career at the nexus of IT and Life Sciences, my experience includes: Ensuring GxP compliance of clinical trial and drug safety systems across cloud-hosted solutions Leading international validation teams Management of software nonconformances (CAPAs and Deviations) Process management/process improvement Supporting internal and sponsor prequalification audits I am interested in Senior Manager/Director positions at a pharma/biotech/medical device organization, clinical research organization (CRO), life-science consulting firm, or a life-science software vendor in similar roles as follows: GxP Computerized System Validation (CSV) Management Life Science Compliance/Validation Management Quality Management System (QMS) Management IT Quality and Compliance Management I am open to hybrid opportunities in the San Diego area as well as remote positions My background includes experience at large corporations (ICON/PRA Health Sciences and Oracle) as well as smaller start-ups Contact Info: 41••••••43 m••••••••@gmail.com
Experience
Senior Manager of IT Operations (Validation, Quality, and Compliance)
Oct 2017 — Present
Managed an international team responsible for validating clinical trial platforms while developing regulatory-compliant validation strategies. • Oversaw SDLC methods for CSV/CSA, maintained quality and compliance documentation, and implemented Risk Impact Assessments including GAMP 5 and Part 11 evaluations. • Supported internal and external sponsor audits.• Drove process improvements through KPI, CAPA, and root cause analysis while identifying and addressing gaps by creating SOPs and work instructions within the QMS. • Led comprehensive validation efforts for company platforms, including clinical research platforms and a software as a medical device (SaMD) platform. • Managed requirements gathering, validation documentation, and yearly Disaster Recovery exercises, including developing plans with defined RTO and RPO metrics and documenting results in DR Reports.
Education
University of California, San Diego (Extension)
Certificate
2001 — 2002
University of California, Berkeley (Extension)
Technical Communications
2001 — 2001
University of Rhode Island
Bachelor of Science - BS
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