Bagsværd Senior QA Professional Capi

Job description

QA Professional, Expansion QA CMC Drug Substance QA Manufacturing Quality Denmark, Bagsværd Are you looking for a job with a lot of interaction with cross functional stakeholders and close teamwork? Are you skilled in navigating complex stakeholder landscapes and do you believe in working together is better than working on your own? Do you value good team spirit where everyone is each other's sparring partners and respect each other's opinions and knowledge? Do you also have a strong quality mind-set and great interpersonal skills and want to use all this solid QA experience in a project context. Do you like a very outgoing job with many contact surfaces then this might be the right job for you. CMC DS QA, Expansion QA team, is looking for a new colleague to be part of projects in CMC API Pilots. The CMC API Pilot facilities are expanding their production capacity for products to clinical trials, and we are looking for a new QA colleagues to work with our QA colleagues allocated for investment projects. We offer you a unique position with a lot of impact in a dynamic environment and an opportunity to really develop your skills professionally and personally. Your new role As the CMC API pilot facilities expand their production capacity for clinical trials and phase 3 manufacturing, we need additional QA Professionals to join our 8 skilled Project QA professionals, supporting expansion projects or the broader CMC API Area. Your main responsibilities include: Delivering top-quality standards in facility and equipment qualification Reviewing and approving qualification documentation Participate in setting the qualification strategy for projects, e.g. by participating in workshops Collaborating across functions with scientists and QA colleagues Assessing requirements and guiding quality decisions for projects Working closely with your peers, you'll help raise compliance levels, solve ad hoc GMP-related challenges, review and approve documentation for facility and equipment qualification as well as other relevant materials for the Pilot facilities. Your skills and qualifications To excel in this role, you should have a strong mindset for quality assurance and a proactive approach to managing quality concerns. Your comprehensive knowledge of pharmaceutical regulations, requirements, and guidelines enables you to navigate efficiently without unnecessary complexity. Required qualifications: MSc in Pharmacy, Engineering, Biology, Chemistry, or related field Experienced in the QA role or production role Minimum 2 years of experience in qualification/validation processes based on Science and Risk based Validation (SRV) principles Deep understanding of GMP Proficiency in English IT Quality qualification experience is a plus but not mandatory. Personally, you are adept at multitasking, capable of making decisions and following up on quality issues and demonstrate ownership and dedication to achieving objectives and delivering outstanding results. You work independently, communicate clearly about complex topics, and take responsibility and initiative. You thrive in a fast-paced setting, value teamwork, and enjoy engaging with diverse stakeholders. Your Team CMC Drug Substance QA employ 37 dedicated colleagues across three teams located in Bagsværd. We ensure quality and compliance for CMC API facilities and equipment as well as the release of raw materials, cell banks, and API for clinical trials. We participate as QA in investment projects to keep Pilot facilities future-ready, continually improving methods and processes to simplify workflows within CMC Quality and Development. You will be part of Expansion QA team consisting of 8 QA professionals. The Team is QA responsible for the API pilot facilities assuring the quality of the facility and the Equipment during the qualification phase and before facility and equipment is released for GMP production. Our team values teamwork, diversity, and humour and we will make sure that you, as our new employee, feel welcome and included. A thorough individual training plan will be made for you together with your mentor. What we offer At Novo Nordisk, you’ll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage. Salary: For this role, the Annual Base Salary ranges from 659,500.00 to 854,900.00 DKK, 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 her e . More information For questions, contact Sr. Manager Charlotte Hellesøe Ørtoft at +45 3075 1742 or Validation Specialist Anne Rønholt at +45 3079 0638. Be advised either Charlotte or Anne will not support queries about your recruitment status. Deadline 25th October 2026. Applications are reviewed on an ongoing basis. Please apply in English and refrain from adding a photo to your CV to ensure fair and efficient processing. We are committed to an inclusive recruitment process and equality of opportunity for all applicants. Note, that automatic screening questions are used as part of the application process for this position. We encourage you to answer these carefully, as they help us assess your expectations, experience and qualifications. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today. Apply now » Find similar jobs: © 2022 Novo Nordisk A/S Disclaimer/Privacy Contact Us