Simon Ghislain

Director, Head of Quality, Life Sciences

Limal, Walloon Region, Belgium

About

With 15 years of experience leading large teams, I excel as a dynamic and visionary leader. My creativity, optimism, and forward-thinking nature make me a natural fit for strategic roles. I possess extensive expertise in Quality within the pharmaceutical industry, specializing in areas such as sterility and data integrity. My proficiency in structured data handling and data-driven decision-making aligns seamlessly with my black belt in lean six sigma, reflecting my commitment to continuous improvement as a core aspect of my professional ethos.

Experience

  • Site Quality Head at Thermo Fisher Scientific
    Sep 2023 - Present · 2 yrs 10 mos

    "Excellence through integrated quality leadership" Site Quality Head - ThermoFisher Scientific, Pharma Service Group, Europe. Site specialized in ATMP (viral vectors) in Cell & Gene Therapy. Leading the entire Quality Unit, encompassing Quality Assurance (QA), Quality Control (QC), Quality Systems (QS), Qualified Person (QP) and other support functions. Responsible for over 70 professionals. Ensuring compliance, efficiency, and a strong quality mindset are embedded across every process. Member of the site's leadership team to guide strategic decisions, risk management, and change processes while maintaining alignment with global standards and policies. Pivotal in driving innovation, fostering a right-first-time mindset, and achieving successful regulatory outcomes that support our business objectives and elevate our site's impact on worldwide health.

  • GSK (Full-time · 14 yrs 2 mos)
    • Director Of Quality Assurance
      Jan 2022 - Sep 2023 · 1 yr 9 mos

      “Quality as a competitive advantage" Director, and Head of Quality for the Rotarix MPU in Belgium. In charge of 30 quality partners throughout the factory, connected to business equivalent. Ensuring that compliance requirements are in place and in use. Advising the leadership team during issues, risk management and change processes to ensure that decisions are taken in the light of effective standards and overarching policies. Accountable for the department’s quality mindset improvement, and for positive outcomes of regulatory inspection.

    • Global Quality Senior Manager
      Jan 2020 - Dec 2021 · 2 yrs

      "Transforming the Quality Systems to be future ready" Data Governance Lead for GSK Vaccines. Member of Global Quality Leadership Team. Global SME on Data Integrity and Data Management (OPEX 1M£/y, CAPEX 60M£). Bridging Business and IT for successful data products. Coaching teams towards an agile mindset, to incrementally bring our quality systems to best in class, data-driven and automated systems. Sponsor of multiple DD&A initiatives within the GSK Vaccines International network.

    • Head of Cleaning Program
      Sep 2018 - Jan 2020 · 1 yr 5 mos

      "Giving directions and managing Stakeholders" Leader of the Cleaning Program initiative on the Siena/Rosia Site of GSK. Matrix management of a multidisciplinary team (Validation, Engineering, QA, QC, PMO), accountable for a 10M£ budget, setting directions to reach site strategic objectives. Embodiment of a remediation/integration strategy, and implementation plan on a risk-based approach. Management of Stakeholders and sponsors on a VP/Director level, raising discussions and influencing investments to meet the program milestones.

  • Founder and Executive Manager at ExcelTab
    Apr 2013 - Aug 2023 · 10 yrs 5 mos

    "My Online Excel Solution Provider" Programming user-friendly solutions for companies. Creation of on-demand tools (ex: interfaces to connect to databases), reparation of defectuous tools, online shop for mainstream Excel tools used in the industry. Working directly with customers to translate their needs into program solutions. Creation of on-demand MS Excel applications. Experience of 100+ projects.