Senior Production Preparation Manager

Job Description
IDD
This position is based in Uppsala, where Thermo Fisher develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and monitoring of allergy, asthma and autoimmune diseases. With 1,900 employees worldwide, and 1,000 in Sweden, we are the global leader in in-vitro allergy testing and the European leader in autoimmunity diagnostics.
How will you make an impact?
Are you interested in a multifaceted role with many interfaces and a lot of responsibility managing projects within a regulatory controlled environment?
We’re looking for an expert Project manager to join our Production Preparation Management team. Your main responsibilities will be to lead and participate in projects within product development, product updates, product registrations and process development.


More about the job
You will work both with introduction of new products and with updates of products and processes. You will be responsible to lead the transfer of new and updated products to regular production with production reviews. The work includes responsibility for production reviews, as well as being involved in developing and improving the production preparation process. You are also encouraged to contribute to the groups and your own way of working being constantly improved and streamlined to ensure quality and delivery of projects and products.
You will lead or participate in multi-functional teams with different competences depending on the projects. This could be colleagues from production, regulatory affairs, Quality Assurance and R&D, process validation and supply chain.
How will you get there?
You currently work in a coordinating role or as a project manager, quality manager, development manager, technical specialist or similar. We want you to have a science or technical university degree. Experience of Design & Development, Design Control and Design Transfer in in-vitro diagnostics or other regulatory-controlled activities in medical technology/pharmaceuticals/life science is vital, as is experience of project management.
The role will suit you with a high focus on quality and documentation. Experience of MDSAP, ISO 13485, FDA QSR and similar regulatory frameworks is important. IVD product knowledge is meriting.
You are driven problem solver and can independently lead. You are an excellent collaborator, who provides clear communication and who are proactive in the way you work. As a person, we believe you are efficient, flexible, enterprising, have strong leadership skills and a coordinated view! Good knowledge of our products and experience with our production flows is strongly meriting.
You can easily communicate in both Swedish and English, both written and spoken.
We highly value personal qualities and motivations.