William Bonville

Quality Assurance Manager R & d Global Quality Operations Genomic Medical Unit @Sanofi

Attleboro, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Quality Assurance Manager R & d Global Quality Operations Genomic Medical Unit @Sanofi

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US

EDUCATION

1991 — 1995

University of Massachusetts Dartmouth

BS, Biology/ Marine Bilogy

SKILLS

Corrective and Preventive Action (Capa)Internal AuditQuality ControlGmpBiotechnologyChange ControlGood Laboratory Practice (Glp)CapaTrackwiseIso 13485SopFdaFda GmpLims21 Cfr Part 11CgmpTechnology TransferGxpQuality AuditingAseptic ProcessingSoftware DocumentationComplianceValidationU.s. Food and Drug Administration (Fda)V&VGlpQuality AssuranceQuality Management

ABOUT WILLIAM BONVILLE

Quality Assurance professional with over twenty years of experience in a CGMP environment with various roles in Quality Systems, Quality Assurance, Quality Control and Manufacturing. Began career as a Manufacturing Specialist, performing Cell Culture and Purification activities. Transitioned to Quality Control performing product testing, environmental water monitoring, and raw material release. In Quality Control, took on supervisory duties, including leading cross functional teams for new product acquisition as well as maintaining lab operations. Transitioned into Quality Assurance and took on roles of increasing responsibilities including auditing, deviation/CAPA review, batch record review, SOP creation and review, and Validation and Change Control review. Leveraging a broad knowledge base in Quality Assurance and CGMP Production, held a Management position acting as subject matter expert in Quality Assurance matters related to product manufacturing activities, as well as the management of the Quality Operations group for daily CGMP activities. Transitioned to Principal Auditor position, using knowledge to manage internal and external audits to ensure CGMP compliance to Manufacturing Operations as well as participating on cross-functional team to ensure inspection readiness. Performed QA function for a start up facility implementing quality systems and supporting validation. Currently Principal Quality Auditor working with CMOs in phase 1/2 clinical development of gene and cell therapies.

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William Bonville — Quality Assurance Manager R & d Global Quality Operations Genomic Medical Unit at Sanofi in Attleboro, MA, US | Unifers