- Responsible for ensuring that all the quality activities and releases during product development are timely completed meeting the business needs of the division and the Authorities and Corporate Quality Standards.- Responsible for ensuring the qualification and performance of EPD sites and contractors. - Responsible for organizing QA resources for the assigned program and align in the team.- Key Quality contact for the assigned program, facilities, projects, stakeholders.- Supporting the governance model with QA Specialists / QP’s to ensure timely and risk based input and oversight for development project.- Empower effectively the QA project team members.- Promote innovation and continuous improvement.- Expert knowledge of global regulations and guidances for the assigned area. - Provide consultation and assistance based on technical expertise and compliance knowledge to support the (Development) stakeholders in the EPD organization and partners.- Manages key quality initiatives for the Development organization.- Act as a Qualified Person according to national legislation. - MSC – PhD in Pharmacy, Chemistry, (micro) Biology, Medicine. - QP qualification according to § 15 AMG. - Leadership and Project management expertise.- Comprehensive understanding of a wide range of Pha ...
