Senior CSV Manager

Time Type: Full Time PLEASE REMEMBER TO CLICK "APPLY" BUTTON AFTER SAVING YOUR PROFILE TO COMPLETE YOUR APPLICATION PROCESS DSV is on the lookout for a Computerised System Validation (CSV) Senior Manager to be a vital part of our IT Healthcare Center of Excellence team. If you thrive on navigating the dynamic landscape of CSV and are passionate about ensuring compliance with industry standards, then this is the opportunity you have been waiting for! As a CSV Senior Manager, you will be at the forefront of implementing validation processes, keeping pace with industry regulations, and leading risk mitigation strategies. Your expertise will shape the future of DSV’s healthcare technology, and your contributions will resonate globally. This is a permanent position within our Global IT organisation, with potential openings available in Denmark, Poland, Portugal, and India. If you are looking for a role where you can apply your skills and knowledge in a dynamic environment, we encourage you to apply. As a CSV Senior Manager, You will: Handle and monitor the implementation of validation protocols, guaranteeing accomplishment and documentation of validation actions in a timely manner Focusing on Qualified Infrastructure in collaboration with our Enterprise Architecture department and other pertinent stakeholders Stay updated on industry regulations, guidelines and best practices linked to CSV and incorporate them into the business's procedure Perform risk assessments as well as offer leadership on risk mitigation methods linked to computerised systems Write validation plans, IQ, OQ, PQ protocols and validation reports for multiple computerised systems Evaluate and sign off on user requirement specifications, functional specifications and risk assessment connected to computerised systems Work alongside cross-functional teams to outline validation needs for new equipment, systems and system upgrades Other duties may be assigned The Ideal Candidate: Is educated to a degree level in a computer science, engineering, life science or similar discipline, though an advanced degree would be ideal 4 years of experience in Computer System Validation, preferably within the logistics or healthcare industry Can Demonstrate experience within computerised systems validation in a regulated organisation such as pharmaceuticals, biotechnology, medical devices, etc. Shows expertise in regulatory needs such as FDA, EMA, etc., as well as industry standards such as GAMP 5, 21 CFR Part 11, etc. connected to CSV Shows leadership and project management abilities with the capacity to efficiently guide a team and handle various projects concurrently Have excellent communication skills, both verbal and written Is able to work effectively with others in cross-functional teams and regulatory agencies Can familiarise with validation documentation, risk assessments, and validation implementation Is fluent in the English language What we offer: Employment contract Private medical care Comprehensive onboarding program Buddy Work-life Harmony Modern eco-office Canteen Comfortable ergonomic office Scandinavian work culture Internal training catalogue Culture of feedback Internal transition program Holiday gifts Sport groups Bike parking DSV – Global transport and logistics