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).
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.