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Lead the nonclinical toxicology strategy across multiple research and development programs, ensuring alignment with program objectives and timelines as well as regulatory expectations; Provide scientific leadership for the design
You are going to play a key global role in ensuring Quality oversight of Bio MSAT activities across internal and external manufacturing. You will drive quality excellence, support technical transfers and validation, and ensure compliance with evolving
You will be responsible for managing the required quality activities and documentation associated with the portfolio of CMOs, ensuring that the CMOs manufacture and deliver products in compliance with Sanofi’s requirements specifications and regulations
Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics are in accordance with the relevant GMPs. Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial
Lead and ensure compliance of global CQA processes across multiple sites; Act as key Quality partner for cross-functional stakeholders (e.g. Clinical Trial Teams, Biometry, CROs); Drive continuous improvement initiatives and proactively identify risks and