Job Description

About the jobDepartment Submissions, Labelling Translations solutions, Digital Data (DD) IT DevelopmentAre you ready to take your career to the next level? Are you passionate about managing critical IT systems? We are looking for an Advanced System Manager I to join our team in DDIT Development GBS department. If you have the skills and experience, we are looking for, read on and apply today for a life-changing career.About The DepartmentIn DDIT Development GBS Submissions, Labelling Translations solutions, a part of DDIT GBS, a portfolio of GxP business critical applications is being managed and supported. These applications are among the most critical IT systems in Novo Nordisk supporting essential processes and being used 24x7 by thousands of users worldwide. Regulatory Solutions works closely with line of Business, System managers, Quality Check (QC)/Quality Assurance (QA) and subject matter experts across the Novo Nordisk IT organization in Denmark and India. We work in Submissions and Labelling (SuLa) ART.The position

• As an Advanced System ManagerI at Novo Nordisk, you will have the following responsibilities:
• Responsible for operation and maintenance of CCMS system. Maintain the validated state of the system.
• Represent system in connection with audits and inspections. Continuous improvement of support/operations processes in teams.
• Managing CCMS system deliverables within agreed schedule, scope, quality, and Budget.
• Manage the CCMS DevOps team activities (Define PI Objective related to CCMS OM, manage features, plan priorities stories, and backlog Refinement.)
• Manage the capacity of the Minister of Environments, overseeing all CCMS environments, including control over GxP environments, accountable for determining the timing and content of deployments into the CCMS environments.
• Manage the expectation of LoB, Customers and users concerning the use of systems (Prepare, provide, and develop the services as agreed).
• Drive Vendor Audit based on Supplier Assessment and own findings, work towards the closure of findings and key Input for Supplier Agreements / Supplier selection.

Qualifications

• To be successful in this role, you should have the following qualifications:
• Bachelor or Masters in relevant field with 10+ years of IT/pharmaceutical experience, with a minimum of 5-6 years of system management experience and knowledge of GxP systems.
• Strong compliance understanding and documented GxP experience from several systems (6-8 years experience).
• Detailed knowledge and experience with system management or past experience as a system manager (6-8 years experience).
• Experience in ITIL processes such as change management, configuration management, release management, incident management, and problem management.
• Extensive CSV experience.
• Experience working with agile delivery models and any SAAS applications.
• Experience in Stakeholder Management, Budget Management and Vendor Management.
• Excellent interpersonal and communication skills including verbal and written communication.
• Ability to represent NN in relation with users and external stakeholders.

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