Head of Global Product Development Quality

Head of Global Product Development Quality

Galderma

La Tour-de-Peilz, Switzerland

The core mission of the role is to lead:

  • Product Quality Leads dedicated to Galderma product development projects being delivered internally and via CDMO (Contract Development Manufacturing Organization).
  • Clinical Supply chain quality for IMP (Investigational Medicinal Products) and non-IMP.
  • Auditing for GMP/GDP internal and external processes as well as facilities.

Key deliveries & accountabilities:

The Head of Global Product Development Quality will have the global responsibility for the quality deliverables related to products in development within Galderma manufacturing facilities as well as CDMOs.

  • Provide guidance, support and leadership to internal and external partners for implementation of quality standard for products/projects.
  • Quality expert for GDP/GMP/ISO requirements during early and late clinical phases.
  • Liaise within project teams and act as a link with clinical, regulatory, production and technical teams during product development.
  • Provide support of product transfers in preparation of product industrialization and launches.
  • Manage the Product QA interface with internal manufacturing, packaging and testing partners for development products.
  • Accountable for products quality assurance, compliance and performance in collaboration with Galderma manufacturing sites and CDMOs.
  • Lead and drive quality aspects of the clinical supply chain channels ( eg. CDMO, third party logistics, …).
  • Responsible for leading quality audits for product development as a means of evaluating compliance and continuous improvement.
  • Direct input to QMS improvements (vendor management, complaints, quality agreements, KPI, deviations) and participate into inspection responses.
  • Lead and direct quality systems improvement programs in collaboration with relevant stakeholders within R&D and other company functions (e.g. Operations).

Work Experience:

  • 15 years of experience in a global leadership role in product development pharmaceutical, or medical device company, critical end-use oriented product industry with strong knowledge of biological products.
  • Experience in an international leadership role both at a global level in a matrix environment is required. Emphasis on equity, innovation and product quality excellence.
  • Ability to move and adapt in a fast-changing business environment.

Required Skills and Knowledge:

  • Master's degree in pharmacy, chemical engineering, pharmaceutical engineering or similar/related fields.
  • Six Sigma/Lean Manufacturing certification is a serious plus.
  • English fluent written and oral, other spoken languages are an asset in building connections with the GBU’s/divisions/regions/countries.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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