Shari Stark
Quality Professional | GCP | Computer Systems Validation | Auditing | 21 CFR Part 11 | Inspection Readiness
- Role
- Director, Gcp Quality at Sanofi
- Location
- Princeton, NJ, US
- LinkedIn followers
- 500 followers
About Shari Stark
I’m a results-oriented Quality Professional with extensive experience in the CRO industry. Experience in audit management, CAPA, root cause analysis, inspection support, computer systems validation, client audits, and vendor oversight. In-depth knowledge of GCP, strategic partnership level quality activities & oversight. Strong understanding of and experience with regulations, directives and guidance’s, governing clinical trials, electronic records and privacy/confidentiality, that includes: ICH E6(R2), 21 CFR Part 11, EU GDPR and US HIPAA.Areas of Expertise- Resourceful problem solver- Excellent communication skills- People management and development- Risk/issue identification, management and oversight- Process Improvement
Experience
Director, Gcp Quality
Apr 2023 — Present
Education
Rochester Institute of Technology
BSEE, Electrical Engineering
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