Silvana Oliveira
Sr. Manager, GCP Compliance, R&D Quality at Vertex
- Role
- Sr Manager Gcp Compliance at Vertex Pharmaceuticals
- Location
- Douglas, MA, US
- LinkedIn followers
- 500 followers
About Silvana Oliveira
Experienced quality, audit, compliance, and operations professional with expertise in the pharmaceutical, biotechnology, and medical device industries in GMP, GLP, GCP, and CLIA/CAP environments. Exceptional organizational skills, cross-functional collaboration, SOP/WI writing and reviewing, general lab training, lead auditing, compliance, documentation, deviations/CAPAs, lab site management, and daily lab operations with attentional to detail, and the ability to multitask. Specialties:Core Competencies:• Write/review standard operating procedures• Lab compliance/in-process/quality systems audits • Metrology/Equipment liaison• Managing of deviations/CAPAs/change control • EMS equipment temperature monitoring• Study report/specimen archivist• New employee compliance training/onboarding• SME on employee training records/ Internal audits• Lead auditor using ISO15189/ISO13485/CLIA/CAP/21CFR820Technical Summary:• Microsoft Word, Excel, PowerPoint, Smartsheets• Nautilus LIMS/STEEL for sample management• Veeva for audit reports/documentation/CAPA• TrackWise/Filemaker/Phenix/Veeva for deviations• MLC/ILEARN/Cornerstone for training documentation• JMP for statistics• Fluent in Portuguese
Experience
Sr Manager Gcp Compliance
Jun 2025 — Present
Education
Framingham State University
B.S., Biology/Biomedical Science
Skills
- Deviations
- Standard Operating Procedure (Sop)
- Auditing
- Fluent Portuguese
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