Sherry Saurini
Head of Quality @ Dendreon | BioTech Pharmaceutical = Immunotherapy + Cell Therapy
- Role
- Head of Quality Dendreon Pharmaceuticals at Dendreon
- Location
- Union City, GA, US
- LinkedIn followers
- 500 followers
About Sherry Saurini
My professional goal is to be responsible for the leadership and growth of a quality assurance and regulatory affairs organization. Senior Quality and Regulatory Leader with successful experience in quality systems for medical devices, biologics, combination products and pharmaceuticals; managing crisis situations, resolving warning letters, OAI inspections and 483 observations. Known for the ability to build & grow a team environment in dynamic organizations. Functional experience authoring and defending 510(k) submissions. Assessing complaints and adverse events for potential field actions. Experience implementing design controls for new product development. Experience with statistical analyses, DfSS principles, validations, auditing and continuous improvement. Experience with preclinical research, audits, and driving continuous product and process improvements.Specialties: Quality Systems, Regulatory Affairs, Medical Devices, Biologics, IVD, Pharmaceuticals510K Submissions, Team Development, Continuous Improvement, Design Controls, Validations, Auditing, Warning Letters, 483 Responses, Statistics, Preclinical Quality, CE Mark Certification, cGMP, GLP, CE Marking, ISO 13485:2016 Compliance, 21 CFR Parts 11, 210, 211, 803, 806, 820, 1270 and 1271. ISO 14971, EU MDR and others.
Experience
Head of Quality Dendreon Pharmaceuticals
Aug 2021 — Present
Executive Committee, reporting to the CEO, I have the honor of leading a Quality team of 150+ as a catalyst of cultural transformation for $300M+ and patients this year. Serving the prostate cancer community, one patient at a time.
Education
Hanover College
BA, Mathematics, Chemistry, German
Georgia State University
MS, Mathematics concentration Statistics
Skills
- Medical Devices
- Capa
- Regulatory Affairs
- Validation
- Cross-Functional Team Leadership
- Iso 14971
- Glp
- Design Control
- Change Control
- Quality Control
- Gmp
- Iso 13485
- Quality Assurance
- Manufacturing Operations
- Continuous Improvement
- Quality Management
- R&D
- Quality System
- V&V
- Iso
- Pharmaceutical Industry
- Fda
- Product Development
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.