Experience

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  Sandoz

  May 2007 - Mar 2012

  Led a team of 95 people with 4 direct reports (Manager of managers) with a direct reporting line to Regional QA ManagerMain responsibilities: To have oversight of all GxP related activities, establish Quality Culture, increase awareness at all levels, set strategy in the quality area in line with our global policies.Manage audit and inspection preparations, quality assessments and recall process. (Led more than 20 audits/ Health Authority inspections e.g. Germany, Taiwan, South Korea, Japan, Pakistan, ANVISA)Worked on a global project as business expert to design and roll out a database (Trackwise) for handling of deviations, laboratory investigations, CAPAs. Played a key role in preparation for FDA Pre-Approval Inspection. Was a certified Novartis auditor (only in GMP area) and audited a couple of suppliers/contract manufacturers Was the only contact with Turkish Health AuthorityLad investigation of 13 recall assessments within 1 year and was able to waive a recall in 7 cases out of 13 through extensive and fact-based investigation Collaborated with Turkish Health Authority for revising local recall regulations Show less

  • Quality Unit Head & Qualified Person

    Jul 2011 - Mar 2012

  • Quality Assurance Group Manager

    Jul 2010 - Jul 2011

  • GMP Compliance Group Manager

    Apr 2009 - Jul 2010

  • GMP Compliance Manager

    May 2007 - Apr 2009
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  Novartis vaccines and diagnostics

  Jun 2012 - Aug 2015

  Was a member of the Region Europe International Leadership team.Led a diverse team overseeing the distribution of vaccines to more than 40 countries within Region Europe & International. Acted as the Quality counterpart of commercial operations.Oversight of country organizations within the region.Led the implementation of new EU GDPs in the region. This was the 1st international assignment within the talent development programFacilitated the implementation of the Novartis Quality Manual throughout the site.Overseen the remediation of Quality SystemTrained the teams remediating quality systems on "establishing a robust and sustainable quality system"Green belt certified (Led a project in QC Lab regarding the supply of reference materials)Led a project to upgrade AQL Program of the site (FDA Commitment)

  • Regional Quality Head Europe International

    Oct 2013 - Aug 2015

  • Quality Systems Head

    Jun 2012 - Oct 2013
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  Gsk biologicals

  Aug 2015 - Dec 2015

  Director, vaccine strategy & performance

  Facilitate the deployment and execution of the enterprise strategyInvolved in building an executive level dashboard comprised of key performance metrics in alignment with companies strategic priorities

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  Acino

  Apr 2016 - Dec 2016

  Head corporate audit
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  Novartis

  Jan 2017 - Jun 2022

  Key player in defining Novartis QMS strategyResponsible for oversight of Novartis QMS landscape, execution of QMS strategy Owner of the QMS framework and document architecture, Ownership of key QMS processes such as QMS document lifecycle management, assessment and implementation of GxP requirementsManagement of Process Owner network, onboarding and continuously coaching and guiding them on QMS processesParticipation in key QMS initiatives

  • Global Head QMS Governance

    Mar 2018 - Jun 2022

  • Head Strategy & PMO Technology Platform

    Jan 2017 - Mar 2018
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  Pharmathen

  Jun 2022 - now

  Vice president of corporate quality management