MICHEL RUEGG, Associate Director, Supply Chain Management, MSD

Expert in digital supply chain operations within the pharmaceutical industry on implementing solutions that improvethe efficiency and effectiveness of supply chain processes and ensure compliance with industry regulations.Led programs related to IDMP, serialization and UDI, which involved ensuring the privacy and security of datathroughout the supply chain. Managed relationships with third-party finished goods manufacturers and technologyvendors, develop sourcing strategies and led a regulatory operations and eCTD publishing team. Contributedto organizational change projects, process improvement and talent development. Track record in Vaccinemanufacturing, both up- and downstream as well as bulk production of highly active pharmaceuticals.

Experience :

Associate Director, Supply Chain Management - MSD
Feb 2021 - Present (2 years 3 months)
•   Digital Supply Chain Connected Channels, enabling blockchain for Security & Traceability use casesin Pharma that focuses on ensuring the effectiveness and efficiency of digital supply chain operationswithin the pharmaceutical industry.
•   I work closely with cross-functional teams to ensure that digital supply chain operations align withbusiness goals and objectives. Am responsible for identifying opportunities for process improvement,designing and implementing solutions, and monitoring performance to ensure that processes areoptimized.
•   Working with external partners and vendors to ensure that the blockchain-enabled solutions are secureand compliant with industry regulations. Responsible for ensuring that data privacy and security aremaintained throughout the digital supply chain.

Manager, Regional Supply Chain Programs - Johnson & Johnson
Jun 2018 - Jan 2021 (2 years 8 months)
•   Leading J&J Consumer Health EMEA Supply Chain Programs with an end-to-end process excellence,legal & compliance focus.
•   IDMP Lead; IDMP (IDentification of Medicinal Products) is intended to facilitate exchange of medicinalproduct information in a robust and consistent manner to improve traceability and safeguard publichealth. IDMP is being adopted as a global standard for data exchange by regulatory agencies and willbe mandatory.
•   Serialization Lead; Implement all Serialization & Traceability requirements in EMEA. Eg. EU FalsifiedMedicines Directive (FMD) requiring tamper-resistant packaging, serialization (point of dispenseverification) or Russian track & trace requirements (tracking at each handling point and for aggregation).
•   UDI Lead; EU Medical Device Regulation readiness on Unique Device Identification (UDI) system toallow the identification and facilitate the traceability of devices.

Manager, External Manufacturing Strategic Sourcing - Johnson & Johnson
Feb 2016 - May 2018 (2 years 4 months)
•   Leading strategic supplier relationship management with selected third parties and technology area(Semi-Solids) linking J&J Consumer’s business needs with external capabilities.
•   Building and implementation of sourcing strategies to support J&J holistic business needs (franchisegrowth drivers and product strategy, QA, Regulatory, R&D, and E2E Supply Chain requirements) and toenable speed to market.
•   Collaboration with other departments to develop and implement best practices, including businessintelligence, risk analysis and due diligence.
•   Aspiration to enable profitable and sustainable growth for new and established products to be producedby contract manufacturers and/or in-licensed and marketed by J&J.

Associate Director, Regulatory Submissions Management & Operations - Johnson & Johnson
May 2014 - Jan 2016 (1 year 9 months)
•   Leading a Publishing Community of Practice team with members from J&J sites in CH, NL, DE and ES.
•   Management and coordination of regulatory operations services to Janssen R&D, Global RegulatoryAffairs and Local Operating Companys in the EMEA region.
•   Contribution to organizational change projects, business process improvement, outsourcing, operationalexcellence, resource management, governance, integration and talent development activities within theglobal Publishing CoP.

Manager, Regulatory Dossier Solutions - Johnson & Johnson
Sep 2013 - Apr 2014 (8 months)
•   Management and coordination of organizational changes and integration of previously Crucell NVRegulatory Operations into Johnson & Johnson Global Regulatory Affairs, Regulatory DossierSolutions.
•   Management of the Regulatory Dossier Solutions team on the Crucell Berne site providing services onregulatory submissions management to the J&J, Crucell vaccines commercial and R&D portfolio.
•   Business Integration Lead on the Johnson & Johnson electronic document management system onbehalf of Crucell.

Head of Regulatory Operations Vaccines - Crucell
Nov 2012 - Aug 2013 (10 months)
•   Managing Regulatory Operations Vaccines group with major tasks in submission management,electronic document management systems and business integration projects within Crucell NV globally.

Project Manager Regulatory Affairs - Crucell
Apr 2011 - Oct 2012 (1 year 7 months)
•   Project lead on implementation of electronic document management systems and processes into GlobalRegulatory Affairs and incorporation of new Regulatory Operations Vaccines group.

Manufacturing Support Engineer, Live Viral Vaccines - Crucell
Oct 2008 - Mar 2011 (2 years 6 months)
•   Linking position between Quality and Regulatory Affairs, Process Development and SeniorManagement to the Operational Unit (Value Stream). Responsible for maintenance and development ofStandard Operation Procedures, Master Batch Records and Manufacturing Documents in general. Partof the Development and Validation/Qualification Teams by setting up new manufacturing processes(Vaccines against Measles and another against Yellow Fever).
•   SAP Key User Operations: Implementing SAP R/3 as new ERP at Crucell N.V. (worldwide), guidanceof creating Process Definition Documents, writing Business Process Procedures and User RequirementSpecifications. Implementation activities alike Integration Testing, User Acceptance Testing and EndUser Training.

Laboratory Assistant Environmental Diagnostics - Bachema AG
Nov 2003 - Sep 2005 (1 year 11 months)
•   Production and Development of Standard Operation Procedures, Guidance of Apprentices andTemporary Employees, Development of Diagnostic Procedures (ISO), Diagnostic of Water for Injection,Drinking-, Technical- and Wastewater, Specific Diagnostics of contaminated Soils (heavy-metals, ions,carbons, toxics), Working Equipments: TOC, IC, GC, etc.

Education :

Bern University of Applied Sciences
Master of Business Administration (M.B.A.), Executive MBA Leadership & Management
2010 - 2014
Business Administration, Leadership, Projectmanagement

Zurich University of Applied Sciences
Bachelor of Science (B.Sc.), Biotechnology
2005 - 2008
Pharmaceutical Biotechnology and Engineering

Skills :
Biotechnology • Regulatory Affairs • SAP Implementation • GMP • Vaccines • PharmaceuticalIndustry • Validation • Project Management • Business Process Improvement • RegulatorySubmissions