Olivia Darmuzey

Founder – Pharmaceutical Quality and Compliance Consulting Services

Olivia Darmuzey
Basel, Switzerland

Experience

Jan 2025 - Present
1 year 1 month
Basel, Switzerland

Founder – Pharmaceutical Quality and Compliance Consulting Services

Tulia Via GmbH

  • Provide pharmaceutical quality and compliance consulting services to early-stage and growing biotech and pharmaceutical companies
  • Support inspection and mock inspection readiness, licensing, and compliant global distribution
  • Support setup and remediation of GMP and GDP compliant Quality Management Systems
  • Provide transitional and fractional Responsible Person services (EU and FvP in CH) to ensure regulatory compliance and business continuity
Jan 2024 - Dec 2025
2 years
Basel, Switzerland

Director, Senior Compliance Advisor – Global QA Compliance

Moderna Switzerland GmbH

  • Provided compliance strategy and regulatory liaison across CMC, digital, and commercial networks
  • Supported inspection and mock inspection management and inspection preparation workshops
  • Led global improvement of quality agreements
  • Implemented Annex 16 aligned digital SAP BTP based supply chain maps
  • Delivered GMP and GDP training and coached junior QA team members across distributed, cross-functional teams
  • Assured regulatory compliance of business and quality processes
Jan 2023 - Dec 2024
2 years
Basel, Switzerland

Director, QA eQMS and Digital Programs – Global QMS

Moderna Switzerland GmbH

  • Supported global SAP S/4HANA implementation and batch release digitalization as QA Business Process Owner
  • Ensured digital business processes met GMP and GDP requirements and data integrity expectations
Jan 2020 - Dec 2023
4 years
Basel, Switzerland

Director, QA Disposition and Batch Release

Moderna Switzerland GmbH

  • Built Moderna Switzerland QMS from scratch during the COVID-19 pandemic
  • Obtained Swissmedic license enabling emergency global distribution of mRNA vaccines
  • Oversaw remote batch release activities for CMO and CDMO produced drug substances and finished products
  • Registered as Responsible Person (FvP) with Swissmedic for Moderna Switzerland GmbH (GDP license including Swiss market release)
  • Registered as EU Qualified Person and Responsible Person with AEMPS for Moderna Biotech Spain S.L.
  • Managed and developed 20 QA professionals, including 6 EU Qualified Persons, based in Switzerland and Spain
  • Established and maintained trusted relationships with health authorities worldwide
Jan 2018 - Dec 2020
3 years
Basel, Switzerland

Head of Quality Operations, Global Supply Chain

Novartis Pharma AG

  • Oversaw quality assurance for global distribution of Novartis’ entire commercial portfolio
  • Registered as Responsible Person (FvP) for 5 mandates with Swissmedic for standard medicines and ATMP GDP licenses (Novartis Pharma AG, Sandoz AG, Novartis Pharma Services AG)
  • Registered as Responsible Person for controlled substances (verantwortliche Person Betäubungsmittel)
  • Successfully led multiple Swissmedic inspections, securing new licenses for ATMPs and a new virtual operating (trading) entity (Alcon spin-off)
  • Managed 10 QA professionals across Switzerland and Slovenia
Jan 2015 - Dec 2018
4 years
Basel, Switzerland

Global Head of Product Transfers, Launches and BD&L – NTO Quality

Novartis Pharma AG

  • Delivered market authorization transfer of approximately 5,000 SKUs across six manufacturing plants during the Alcon integration
  • Supported GSK oncology portfolio transfer to Novartis and Over The Counter divestment to GSK
  • Drove global QA oversight for product launches, site transfers, and licensing activities across aseptic platforms
Jan 2012 - Dec 2015
4 years
Huningue, France

QA Operations Head and QP Delegate – BiopharmOps

Novartis

  • Managed QA operations for biologics drug substance release (monoclonal antibodies)
  • Led and developed a team of 15 QA professionals
  • Supported FDA approval (submission and pre-approval inspection) for Cosentyx
Jan 2010 - Dec 2012
3 years
Stein, Switzerland

Production Manager – Solid Dosage Form Manufacturing

Novartis

  • Managed a solids galenic manufacturing unit producing over 2 billion tablets per year across 30 brands
  • Supported validation activities and global product launches
  • Supported successful inspections from FDA, EMA, Swissmedic and other regulatory authorities
Jan 2008 - Dec 2010
3 years
Stein, Switzerland

QbD Expert – Solid Dosage Form Manufacturing

Novartis

  • Introduced Quality by Design concepts into manufacturing operations
  • Supported successful EMA and FDA inspections for PAT and real time release testing products
Jan 2003 - Dec 2008
6 years
Brussels, Belgium

Development Scientist

FMC Biopolymer

  • Developed innovative oral solid dose systems (NRobe, alginate based soft capsules)
  • Inventor on four patent applications
Jan 2002 - Dec 2002
1 year
France

Scientist – Thesis Internship

Pierre Fabre

  • Freeze drying optimization and analytical method development

Summary

Senior Pharmaceutical Quality Leader with 23 years of international experience across pharmaceuticals, biologics, ATMPs, and mRNA vaccines.

Extensive expertise in GMP and GDP compliance, Quality Management Systems, batch release, and direct interaction with regulatory authorities like Swissmedic, EMA, FDA, and MHRA.

Proven track record as Responsible Person (EU and FvP in CH) and EU Qualified Person (QP) in commercial, pandemic, and fast-paced start-up environments. Currently providing pharmaceutical quality and compliance consulting services supporting QMS setup, inspection readiness, licensing, and compliant global distribution.

Skills

  • Gmp Compliance

  • Gdp Compliance

  • Quality Management Systems

  • Responsible Person Mandates

  • Qualified Person Mandates

  • Eu Batch Certification

  • Batch Release

  • Regulatory Authority Interaction

  • Inspection And Mock Inspection Readiness

  • Audit Management

  • Deviation Management

  • Capa Management

  • Change Control Management

  • Annex 16 Compliance

  • Mrna Vaccines

  • Biologics

  • Atmps

  • Supply Chain Quality Oversight

  • Quality Agreements

  • Digital Quality Systems

  • Sap S/4hana

  • Veeva

  • Trackwise

  • Quality Leadership

  • Change Management

Languages

French
Native
German
Advanced
English
Advanced

Education

Oct 2002 - Jun 2003

University of Lille

Master’s Degree, Industrial Pharmaceutical Sciences · Industrial Pharmaceutical Sciences · Lille, France

Oct 1996 - Jun 2002

University of Bordeaux

Doctor of Pharmacy · Pharmacy · Bordeaux, France

Certifications & licenses

EU Qualified Person

AEMPS

Responsible Person

AEMPS

Responsible Person (FvP)

Swissmedic

Swissmedic License

Swissmedic

Responsible Person (FvP)

Swissmedic

Responsible Person For Controlled Substances

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