Edel Ryan

Experience

• 

  Smithkline Beecham

  Sept 1996 - Feb 1999

  QC Analyst

  • Successfully implemented and validated LIMS • Routine QC Responsibilities

• 

  Pfizer

  Jan 1999 - Jan 2012

  Compliance

  While at Pfizer I held various roles including:Compounding Team Leader, Pfizer Inc, Brooklyn, NYC• Managed a team of 21 colleagues in a culturally diverse environment• Introduced and managed a program that increased documentation right first time (RFT) index by 70%• Conducted internal and external audits in the USA on behalf of the site• Responsible for achievement of monthly manufacturing/financial goalsSupplier Quality Specialist, Loughbeg Drug Product Facility, Co. Cork• Initiation and management of Supplier KPIs, Certification programs, Service Level Agreements, Complaint System and Monitoring of Vendor Quality• Member of Global Corporate audit team auditing suppliers across Europe and USAGlobal Sales & Operations Planner, Loughbeg Drug Product Facility, Co. Cork• Establish net demand on facility through Global S&OP for Lipitor, the largest selling Pfizer Pharmaceutical product• Maintain facility S&OP process to provide real-time visibility and manage capacity, supply, demand and inventory.QA Specialist, Loughbeg Drug Product Facility, Co.Cork• Green field site start up: Develop and implement Pfizer policies and procedures resulting in successful IMB and FDA audits• Implemented a lean batch review cycle, decreasing inventory by 80%• Independently audited external Raw Material and Component suppliers, and distribution facilities for compliance with ISO 9001, 21 CFR and ICH guidelines across Ireland, Europe and USA• Conducted internal audits for compliance with corporate and site internal procedures, 21 CFR, European Commission Regulations and ICH guidelinesSupply Chain, Pfizer Operational Support Group, Co. Cork• Irish Representative on European Transportation Team• Lead Irish logistics team, drive compliance with European/global transportation requirements• Manage current Irish PCC/IPs and initiate new PCC/IP authorisations Show less

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  Amgen

  Apr 2013 - Jul 2014

  Quality Systems Improvement Lead

  Project Manager of multiple Quality Systems improvement workstreams

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  Mylan

  Aug 2014 - Jun 2019

  • Director Quality Biologics/Derm/Respiratory

    Mar 2017 - Jun 2019

  • Senior Manager Complex Products Quality

    Jun 2015 - Feb 2017

  • Project Manager Complex Products Quality

    Aug 2014 - Jun 2015
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  Viatris

  Jun 2019 - Nov 2021

  Director Quality OSD Europe
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  Bristol Myers Squibb

  Nov 2021 - now

  Director Program Management