Kymos is a CRO that provides development services for pharmaceutical, biotechnology, veterinary, fine chemistry, cosmetics, and nutraceuticals industries. The main areas of activity are the following ones: Immunogenicity studies and immunoassay of innovative biological drugs, biosimilars and vaccines. Bioanalysis in preclinical and clinical studies, including full bioequivalence studies. Quality control, stability studies and analytical development of drug substances and drug products (physico-chemical and microbiological testing) Process analytical technology services, using NIR and RAMAN and QbD strategies. Kymos is certified in GLP's and GMP's compliance and it has been authorized as partial manufacturer in quality control. Develop goals and strategies to ensure the IT department runs smoothly and effectively. Direct and establish IT-related projects. Monitor changes in the technology sector to discover ways the company can improve and develop. Supervise the networks and computer systems in the company to ensure optimal performance. Plan and direct the implementation of new IT systems. Troubleshoot data-related issues and establish regular maintenance. Special back up plan data Have available a System and data Recovery Plan Identify conflicts of interest between different areas for prioritization of IT resources, escalating risk situations. Maintain the know-how on IT instrumentation issues as software, firmware, drivers, … Administration of computerized systems that generate data from studies carried out in GXP environment in the activities of Kymos Group. Security Officer. Responsible for overseeing information security, cybersecurity and IT risk management programs based on industry-accepted information security and risk management frameworks. Functions Group Level: Manage IT Budget. Forecast and develop budget requirements and expenditures, also CAPEX. Interact with business departments, suppliers and departmental managers at the highest level. Provide the drafting of the project follow-up reports to the direct responsible. Provide leadership to IT specialists and other staff within the company. Create and adapt technological platforms to improve the client experience. Coordinate transversally to both internal and external development teams and the business areas involved, so that the solutions implemented meet the requirements requested and the quality standards established by the entity. Perform a post-start-up follow-up to analyze potential incidents and resolve them within the warranty period. Approve and evaluate proposals from suppliers ensuring their visibility for billing control. Coordinates the continuous development, implementation and updating of security and privacy policies, standards, guidelines, baselines, processes, and procedures in compliance with local, state and UE regulations and standards. Develop and manage the frameworks, processes, tools and consultancy necessary for IT to properly manage risk and to make risk-based decisions related to IT activities. Proactive identification and mitigation of IT risks as well as responding to observations identified by third party auditors or examiners while assisting in the development of periodic reports and dashboards presenting the level of controls compliance and current IT risk posture. Assist staff with the audits and facilitate management response and remediation efforts. Ensure overall IT compliance with regulatory requirements through proactive planning and communication, ownership and relationships. Identify acceptable levels of residual risk and assist with action plans, policy and procedural changes for risk mitigation. Provide strategic recommendations to key IT projects to help improve project results, quality of deliverables, risk optimization, security processes and compliance with regulations. Receives allegations of security incidents and conducts complex investigations; prepares written findings, recommendations and follow up evaluation; and analyzes patterns and trends. Senior Asset Management Specialist (m/f/d) - IT Operations SAP & Applications Manager - Cliente final Healthcare #J-18808-Ljbffr
