QMS Professional for API pilot production facilities

Job title: QMS Professional for API pilot production facilities

Company: Novo Nordisk


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Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading…CategorySelect how often (in days) to receive an alert:×Select how often (in days) to receive an alert:QMS Professional for API pilot production facilitiesCategory: QualityLocation:Bagsværd, Capital Region of Denmark, DKWould you like to help us secure the quality level of our pilot plants within a growing portfolio of pharmaceutical products? Do you want to expand your knowledge within pilot production processes used to purify APIs of the future? If yes, then you could be our new colleague as Quality Management System (QMS) Professional. Apply today and join us for a life-changing career!The position
You will be responsible for driving quality activities, and for sustaining and developing the overall quality level across several production facilities. You will be working closely together with the production teams, management, as well as the QMS partner and other QMS professionals in the area. Your day-to-day tasks will consist of a combination of desk work and collaborative work, such as facilitating workshops, visiting shop floor, guiding colleagues, and participating in board meetings. More specifically, you will:

• Lead and facilitate bi-weekly deviation board meetings, ensuring effective follow-up and alignment
• Drive strategic quality projects, including deviation reduction and cross-organizational improvements in collaboration with the QMS partner
• Prepare for and support internal and external audits, from planning through to execution and follow-up
• Monitor quality performance by trending deviations and compliance metrics, identifying areas for continuous improvement
• Act as a trusted sparring partner to technicians, scientists, and engineers on quality topics, helping set direction and find solutions
• Train colleagues on GMP, GDocP, and QMS requirements

QualificationsTo succeed in this role, we imagine you have:

• A master’s degree in chemistry, biotechnology, or a related field, along with at least 5 years of experience in quality management systems within the pharmaceutical industry (API production experience is highly preferred)
• Solid understanding of GMP, FDA, EMA, and ICH guidelines, with hands-on experience in quality audits, deviation handling, and Systematic Problem Solving (SPS)
• Strong analytical skills and the ability to navigate complex processes while maintaining a clear overview
• A collaborative mindset and proven ability to align diverse stakeholders and drive results across functions
• A proactive, accountable approach with confidence in decision-making and solution-finding
• A genuine interest in shop floor operations, with the ability to engage with colleagues and contribute effectively in a fast-paced production environment

Additionally, certifications in quality management (e.g., ISO 9001) will be considered a plus.About the departmentWe are 70+ employees in the Chemical Manufacturing & Control (CMC) API Pilots Purification department, divided into five teams, and two facilities. Our task is to scale up processes and purify proteins for toxicological and clinical studies. We are part of the Novo Nordisk CMC and Product Supply unit, responsible for manufacturing and distributing products to markets and patients all over the world.You will be part of the production support team consisting of approximately 20 highly skilled academics and principal technicians, responsible for supporting the department within QMS, cLEAN, training, external environment, and equipment qualifications.Working at Novo NordiskAt Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.ContactIf you have any questions, do not hesitate to reach out to Christina Anne Storgaard at csgd@novonordisk.com.Deadline10 August 2025.Applications will be reviewed continuously, and we will begin conducting interviews already during the posting period, so please do not hesitate to apply.You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Expected salary:

Location: Bagsværd, Hovedstaden

Job date: Wed, 09 Jul 2025 05:33:50 GMT

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