An Wolfe
Process & Compliance Lead - Finished Goods Value Stream @Genentech
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WORK HISTORY
Process & Compliance Lead - Finished Goods Value Stream @Genentech
Hillsboro, OR, US
Lead team of operational associates tasked with performing training/development, deviation management, and quality system activities for inspection and packaging process units.• Responsible for driving operational effectiveness of the Finished Goods Value Stream enabling the reliable OTIF delivery of commercial production commitments in a safe and compliant manner.• Represents the Finished Goods Value Stream in regulatory inspections and serves as single point of contact (SPOC) for triage of all compliance related needs/requests.• Accountable for end-to-end process and systems management in the areas of business performance, business analytics, Lean Production System (LPS) integration, Master Data management, UPE/CAPA management & RCA, and GMP development training programs.
EDUCATION
University of Virginia
Bachelor of Science (BS), Biomedical/Medical Engineering,
ABOUT AN WOLFE
Director of Quality Assurance – Quality Engineering & Validation
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