Bohumil IT Compliance And Operation Lead Jeva

Job description

As IT Compliance and Operation Lead in Global Manufacturing & Supply, you will make sure the IT systems and computerised equipment behind our laboratories, manufacturing, utilities, facilities and warehousing are validated, compliant and ready for inspection. You will set the direction for how validation is done, guide project teams and lead a small team. Your work supports the reliable production of treatments for people living with serious chronic diseases. What you’ll bring To succeed here, you combine hands-on validation experience with the judgement to keep compliance practical and clear. • A Bachelor’s degree in Information Technology or a related field from an accredited college or university. • At least 5 years of experience in IT compliance, preferably in pharmaceutical API and/or finished-product manufacturing. • At least 3 years of experience in validation and testing of IT solutions. • Experience as a subject matter expert in audits and inspections. • Experience with GxP, change management and deviation handling. • Experience with incident, problem and change management in IT. • Excellent customer service, problem-solving, negotiation, conflict management and interpersonal skills, with the ability to collaborate effectively in a team. • Excellent planning, organising and decision-making skills, and the ability to deal with complexity and ambiguity. • Excellent written and spoken communication skills in Czech and English. Useful, but not essential: • Experience of leading or developing people, as this role starts with one direct report and may grow. What you’ll do You will be the go-to expert for computer systems validation (CSV) across Global Manufacturing & Supply, helping teams deliver IT solutions that meet regulatory expectations without slowing the work down. • Lead validation activities for IT infrastructure, IT systems and computerised equipment supporting laboratories, manufacturing and business areas such as utilities, facilities and warehousing. • Make sure IT solutions comply with relevant regulations and standards, including 21 CFR Part 11, EU Annex 11, GAMP and NIS2. • Facilitate, review, approve and, where needed, develop validation deliverables such as URS, DQ, FMEA, risk assessments, FAT, SAT, IQ/OQ/PQ protocols, and operating and maintenance instructions. • Carry out risk assessments and impact analyses to spot potential compliance issues early and agree how to mitigate them. • Guide and support project teams on validation and qualification requirements. • Keep improving documentation and processes, find efficiencies in the CSV approach, apply lessons learned and stay on top of regulatory changes. • Ensure compliance with Novo IT QMS requirements and lead the harmonisation of the local IT QMS with Novo standards. • Lead and develop your direct report, with the potential to grow the team over time. Who you’ll work with You will join Global Manufacturing & Supply, where colleagues work across the value chain from drug and device development to marketed Novo products, scaling molecules, processes, devices and products for the people who need them. You will lead one team member to begin with and work closely with Information Technology colleagues. Your day-to-day partners will be project teams, system owners, and colleagues in laboratories, manufacturing, utilities, facilities and warehousing, as well as quality stakeholders. You will also represent the area as a subject matter expert in audits and inspections. Clear priorities, honest conversations and quick decisions will help you move validation work forward together. What you can expect here You will be trusted to own your area and make your voice heard on how compliance is built into IT solutions. The role gives you room to improve ways of working, share your expertise and grow as a people leader, supported by clear performance expectations and relevant learning offerings. You will build new skills through close collaboration across IT, quality and operations. Salary For this role, the Annual Base Salary ranges from 1,188,980.00 to 2,080,720.00 CZK corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge and relevant experience. Incentives and benefits The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy Total Rewards & Benefits Start now Your impact begins today. If you are ready to bring clarity and compliance to the systems that support our manufacturing, apply for the IT Compliance and Operation Lead role by 17/11/2026. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Apply now » Find similar jobs: © 2022 Novo Nordisk A/S Disclaimer/Privacy Contact Us