stillingsbetegnelse:
IT System Manager with strong business orientation & quality mind-set

jobbeskrivelse:
- IT - Denmark - Måløv Do you want to play a key role in developing and improving the IT system management processes in Chemistry, Manufacturing and Control Development (CMC) Development in Novo Nordisk? Do you have a strong quality mind-set combined with a wish to provide broad support within IT quality management? Then you could be our new colleague in CMC Clinical Supplies Business and IT Support (CSBITS). About the department Chemistry, Manufacturing and Control Development is a part of the Research & Development organisation, developing molecules into commercial products for nonclinical and clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. CMC Development is organised in six areas of expertise supporting the entire drug development pipeline. Working in CMC development, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted CMC Clinical Supplies (CS) is responsible for filling, planning, packaging and delivering supplies for the clinical trials in Novo Nordisk. Located in Måløv, CSBITS is responsible for managing strategic projects and analyses that aim at increasing the efficiency of the clinical supply chain. CSBITS is a department of 16 highly skilled people who work across CS. We carry out strategic projects and analyses that aim at increasing the efficiency of the clinical supply chain. We work analytically and data based and support CS Management with high quality decision support and solutions. The department is responsible for a number of IT systems. The open position is in Production Management Xystems (PMX) and system management team where we are dedicated to support CMC departments with IT system management, IT project management and PMX support. The position As IT system manager you will be responsible for the operation and maintenance of one GxP critical IT system used for global temperature logging, as well as for 3 smaller IT systems categorised as non GxP, a planning tool, a simulation tool and a data warehouse all supporting clinical supplies supply chain. You will be responsible for ensuring that the IT systems are in compliance with internal and external requirements (according to health authorities) to ensure the validated state. As an IT system manager you will be the validation specialist for the IT systems that you will be responsible for. The development of the system is not part of the job. You will be supervising the operation and maintenance of the IT systems which are supporting supply chain processes, identify new requirements and manage the expectations of customers, system owners and other key stakeholders concerning the use of the IT systems (Change Advisory Board (CAB)). You will communicate and collaborate closely with the key stakeholders including follow-up on vendor deliverables and services according to agreements. All systems are reported to Change Advisory Board and System Advisory Board (SAB). The progress of yearly activities must be tracked, these activities contains system compliance activities that are mandatory in order to be inspection ready. Business oriented system strategies are also an important task and here is the system manager the key driver. In CMC development we have strong focus on ensuring the right level of IT compliance. As a part of this focus, we are managing a number of improvement activities. Qualifications You have a strong background within computer or device validation, preferably with experience from the pharmaceutical industry or working with supply chain processes in a regulated environment. You are able to understand business processes in IT systems. You hold a relevant academic degree, along with 3-10 years of working experience. As a person you have a structured approach to challeng

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Systemanalytikerarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark