SB

Sebastien Bettinger

Head of Quality at Sumitomo Pharma Switzerland

Switzerland

Overview

Work Experience

  • Head of Quality, Swiss Responsible Person

    2024 - Current

  • Business Angels

    2020

  • Vineyard owner

    2020

    Owner of organic "Grand Cru" premium wines, in Alsace.

  • Head of Quality International & (a.i) North America

    2022 - 2024

  • Senior Director, Head of QA EMEA, Russia & APAC

    2020 - 2024

    Affiliates oversight QA Projects & Due Diligence GxP Lead auditor

  • Director, Senior QA Advisory

    2020 - 2020

    Due Diligence Business expansion Project lead CGP Auditor

  • Senior GxP QA Manager

    2019 - 2019

    Head External GMP/GDP vendors management, audit/compliance. Support the GCP Inspection Readiness Program and related activities

  • Quality Compliance & EU Qualified Person / Responsible Person

    2018 - 2019

    Brexit Tech Transfer Project Management SAP & MES QA support Mock inspection Contract QP/RP

  • QA Director, Knowledge, Trending, Learning & Development / Qualified Person

    2016 - 2018

    Establishment of processes to benchmark with industry experts in order to identify key regulatory focus areas and set strategic audit direction (GCP, GMP, GDP) observations) Utilization of historical and ongoing audit data to establish priorities for the audit plan and subsequent schedule Development of departmental learning management to include curricula development and maintenance, courseware and training events, ongoing learning opportunities, and management of associated documentation Conduction of departmental development training regarding key topics, GxP trends, and regulatory issues Liaison with Operational functions to communicate findings and trends Development of coordinated Data Integrity strategy

  • Site QA Head - Compliance & Distribution / Qualified Person

    2015 - 2017

    GxP QA auditor Complaint lead investigator Global QA supply compliance External Quality Drug substances Qualified Person / Responsible Person Implement and maintain Quality agreements with Global vendors

  • a.i. Supplier QA Head - External Quality

    2015 - 2016

    Lead External Suppliers Qualification process for EPD market. Manage the quality aspects of the relationship in accordance with the effective Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues. Review and update, if required, analytical specifications, APQR. Manage/Approvequality topics(.e. deviations, complaints, change requests). Ensure that materials and produced and shipped in compliance with Quality Agreement and Regulations.

  • Senior Manager, Global Compliance & Distribution / Qualified Person

    2014 - 2015

    GxP support to Manufacturing sites Narcotics Certified Global Lead QA auditor- coordinates Audit program Inspection readiness - Training Regulatory Intelligence Sr QA Warehouse Manager (acting as QA Head/ QP)

  • Global Distribution QA Manager / Qualified Person

    2012 - 2014

    Global Commercial & Distribution QA Manager GMP and GDP support to Affiliates, Manufacturing and Distribution sites Supply chain On-site audits

  • QA & Release Manager External Supply - Deputy Head of Release - Project coordinator

    2010 - 2012

    Release activities: marketed producted (Biologic and small molecules: syringe, ampoule, tablet & capsule, syrup) Complaint lead investigator for Roche Affiliates. Discrepancy management, CAPA system Assessing quality trends and implementing Capability index. Ensure that PQR's are issued by CMO, on a yearly basis, in line with Technical Agreements. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues. Develop project plan Track actions Maintain minutes and presentations Cross functional team: Business and Quality

  • QA expert Biotech

    2010 - 2010

    QA expert for the Manufacturing Technology unit (Novartis Biotech). Main activities of the unit : Cell culture, Purification, Analytics Support to the production units :Technology Transfer, Investigation, Troubleshooting, ... CAPA & Change control coordinator

  • Qualified Person - Head of Quality

    2007 - 2010

    I'm both Deputy QP pharmacist at R&D site (pre-clinical to clinical trials phase I) in Strasbourg, France and at the Manufacturing site (clinical trials phase II to commercial) in Colmar, France. Set-up QA system at R&D site in Boston, Mass (US) in compliance with cGMP, including analytical, formulation and manufacturing parts. This site provides full scale-up service from pre-clinical to commercial products. Responsible for pharma presence and compliance activities. Auditor Set-up CAPA IT and CSV Follow-up KQI Moderator (Inspection relationship management) during regulatory inspections, corporate and customers audits

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