Job Description

The position As a Senior IT Validation and Compliance Specialist I at Novo Nordisk, you will have the following responsibilities: Define and execute validation and qualification strategies for GxP Computerized Systems, Computerized Equipment, Infrastructure, or Robotic Process Automation (RPA) and Emerging Tech such as Artificial Intelligence (AI) and Machine Learning (ML). Develop validation plans, validation reports, design reviews, test strategies, and execute validation activities. Ensure systems are in compliance with relevant internal and external regulatory requirements. Participate in audits and inspections, identifying and implementing solutions to compliance gaps. Provide compliance consulting for IT projects and deliver compliance deliverables related to Computer System Validation (CSV). Manage multiple concurrent tasks and be flexible in handling complex projects. Mentor and guide junior colleagues in validation activities. Qualifications To be successful in this role, you should have the following qualifications: You hold Bachelors or Masters in relevant field with minimum 10+ years of experience in working in a service -based organization/pharmaceutical industry preferably in the IT quality domain and preferred to have Industry recognized ITIL and ISO quality management certification. You should have minimum 7+ years of practical experience in GxP areas with exposure to regulatory affairs, 7+ years in performing Root Cause Analysis (RCAs), 2+ years in service management and any other relevant IT quality activities. Proven management skills in quality as well as validation activities and Global Stakeholder Management in Pharmaceutical field and expertise in SDLC and STLC. Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11), GxP, self-driven to ensure that the IT systems will pass inspections from the authorities without problems. You should have experience in Risk assessment and exposure to Test management tools such as HP ALM. Should be able to effectively manage employee utilization and maximum efficiency with right balance on employee engagement, coach and develop employees. Expert in performing validation?activities for complex projects and ability to represent NN in relations with users and external stakeholders. Strong interpersonal, analytical, communication and collaboration skills and ability to represent NN in relation with users and external stakeholders.