Sebastien Bettinger

Head of Quality, Swiss Responsible Person

2024

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