Lisa Erez Email and Phone Number
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•Sixteen years Quality Assurance and Compliance experience in the Biotechnology Industry •Four years experience as a Site Process Owner (SPO) for multiple Quality Systems •Nine years experience of Quality oversight at Contract Manufacturer Organizations (CMO) and Partnerships •Certified auditor specializing in audits of CMOs and Quality Systems audits •Expertise in Inspection Management and Preparation during regulatory inspections•Represent Contract Manufacturing Quality during Amgen internal audits and regulatory inspections •Excellent project management skills •Strong communication, negotiating and organizational skills, effective in facilitating interdepartmental and cross functional communication and interactions •Development and delivery of presentations for Executive Management, Global Operations and Product Quality Team meetings •Knowledge of regulatory requirements including 21 CFR Parts 11/210/211/820, EU GMPs and ISO 13485
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Senior Manager Manufacturing External SupplyAmgen Jul 2019 - PresentThousand Oaks -
Senior Manager Quality Assurance Supplier Quality ManagementAmgen Jun 2017 - Jul 2019Thousand OaksQuality lead for single use systems, responsible for the oversight of two key suppliers.
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Senior Manager Quality Assurance/ComplianceAmgen Nov 2012 - Jun 2017Thousand Oaks•SPO, program management and representative for multiple Quality Systems, including Audits & Inspections, Risk Management, Managing Contractors and Quality Agreement networks•Perform audits of internal Quality Systems to ensure compliance with Amgen standards•Maintain internal and external clinical audit program•Ensure compliance with regulatory and corporate audit commitments at contract sites•Supported several Pre-Approval Inspections at CMOs •Tracking, trending and reporting of Quality metrics •Support Annual Product Review cycles, nonconformances, CAPAs and change controls
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Senior Manager Quality Assurance Contract ManufacturingAmgen Oct 2007 - Nov 2012Thousand Oaks, Ca•Managed three direct reports responsible for the Quality site management of contract manufacturers•Quality liaison between Amgen and several CMOs and Partnerships•Knowledge of medical devices•Successful negotiation of Quality Agreements with CMOs and Partnerships•Development of site procedures •Coordinate cross functional team activities between the CMO, Supply Chain, Business Project Manager and internal Amgen departments to continuously meet company targets and ensure patient supply
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Quality Compliance Manager Contract ManufacturingAmgen Oct 2006 - Oct 2007Thousand Oaks, Ca•Small Molecule Compliance Lead Auditor•Led preparation efforts for FDA inspection focusing on contract manufacturing oversight•Participated on Inspection Preparation teams for regulatory Pre-Approval Inspections (FDA, Health Canada, TGA) through the site Inspection Management program•Key member of the Inspection Preparation room during regulatory and corporate audits•Executed and maintained internal audit program•Provided site Inspection Awareness Training to prepare for internal corporate audits as well as routine regulatory inspections•Sponsored development of training material for the Small Molecule Compliance Auditor Training•Served as Quality Compliance representative on three cross functional teams representing three clinical products at various phases
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Associate Manager Small Molecule QualityAmgen Mar 2004 - Oct 2006Thousand Oaks, Ca•Lead Quality representative with responsibility for oversight at two CMOs •Supervised one Project Specialist whose primary responsibility was batch record review and resolution of internal investigations as well as at the contract site•Disposition Manager for commercial and clinical distribution encompassing protein and small molecule products from drug product and packaging activities•Reviewed and approved contract manufacturing documents such as batch records, material specifications, master packaging configurations, analytical methods and validation protocols•Interacted with contract site Quality representatives to conduct failure investigations, process change controls and reviewed validation protocols•Created and maintained databases to track and trend product release timelines and supporting batch documentation•Served as department representative on the Investigations All-Site team
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Quality Assurance ManagerBiomarin Pharmaceuticals, Inc. Jan 2000 - Sep 2003Novato, Ca•Disposition Manager for bulk drug substance and finished drug product lot files for commercial and clinical distribution•Oversight of contract site operations including bulk production, fill/finish and label/pack activities•Member of review team for approval of cGMP documents such as quality agreements, batch records, change controls, deviations, specifications, and validation protocols•Supervised a team responsible for batch lot review and investigation resolution•Provided support to Regulatory Affairs for CMC sections on regulatory filings for Aldurazyme® and Naglazyme®•Participated in FDA and EU PAI inspections for Aldurazyme® in October 2002 -
Research AssociateAmerican Protein Corporation Sep 1996 - Dec 1999Ames, Iowa•Supervised three individuals in Pet Nutrition R&D while developing palatable flavors for the pet food industry•Responsible for the organization of daily laboratory activities, scheduling of feeding trials and analysis of statistical data from companion animal feeding trials•Performed lab assays in support of product release
Lisa Erez Skills
Lisa Erez Education Details
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Biochemistry -
Regulatory Affairs
Frequently Asked Questions about Lisa Erez
What company does Lisa Erez work for?
Lisa Erez works for Amgen
What is Lisa Erez's role at the current company?
Lisa Erez's current role is Senior Manager Manufacturing External Supply.
What is Lisa Erez's email address?
Lisa Erez's email address is li****@****ail.com
What is Lisa Erez's direct phone number?
Lisa Erez's direct phone number is +132386*****
What schools did Lisa Erez attend?
Lisa Erez attended Canisius University, San Diego State University-California State University.
What skills is Lisa Erez known for?
Lisa Erez has skills like Quality Assurance, Gmp, Biotechnology, Quality Auditing, Quality System, Contract Manufacturing.
Who are Lisa Erez's colleagues?
Lisa Erez's colleagues are Colby Allen, Karen Ashton-Sterling, Diane Richardson, فايز العنزي, Tj Xiang, Jim Wagner, Stephanie Lilienthal.
Not the Lisa Erez you were looking for?
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Lisa Benjamin Erez
Web Design | Landing Pages | Catalogs | Online Stores For Service Providers, Creatives & Ngo'S 🌈 Lover Of Color...But Sea Blues Are My Fave 🌊. Acrylic & Resin Artist In My Spare Time 🎨.Israel2studio-lisa.com, studioerez.com2 +972524XXXXXX
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Lisa Erez
Innovative Marketing And Bd Leader | Pharma, Healthcare, Biotech | Israel & CanadaTel Aviv District, Israel3janssen.com, gmail.com, gmail.com
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