(Senior) Quality Coordinator
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Are compliance and efficiency core values for you? Are you always ready to initiate and join activities that will secure the right level of quality and compliance by applying LEAN principles? Do you enjoy analysing data to spot trends that call for action? Then, this is your chance to take the next step in your career and gain more responsibility for processes and quality in all GMP departments located in Chemistry, Manufacturing and Control (CMC) Active Pharmaceutical Ingredien (API) Development area. Join CMC API Development as our Quality Coordinator. Apply now! The position In collaboration with the four GMP management departments, you will drive the quality and compliance agenda across the CVP area. You will function as a one-point-of-entry for audits and inspections in the area and drive the planning and execution. Additionally, you ensure our Quality Management System (QMS) system is compliant with the global procedures and that quality activities are executed. Specifically, your main responsibilities will be to: Strengthen the QMS by ensuring compliance of our working processes and procedures Be the go-to person on quality subjects; you actively identify and drive quality improvement initiatives, and support as needed by applying systematic problem-solving, process mapping, or other LEAN methodologies Participate in the CMC quality-related networks and coordinate input to the Quality Management Review on behalf of the CVP area Join the planning, preparation, and execution of audits and inspections in CMC API Development and contribute as a resource during audits and inspections in the area Responsible for the area’s deviation trend reporting, quality monitoring setup, content overview, security risk assessment, and other quality reporting documents owned at CVP level Support and drive the yearly planning of quality activities to be performed across departments Qualifications To thrive and succeed in this role, we expect you to have: A scientific academic degree in engineering, biology, chemistry, or another relevant discipline at master level or above A minimum of 3 years of experience within GMP and compliance Experience with quality regarding quality and GMP Demonstrated project management skills or experience As a person, you are curious, with a LEAN mindset. You are capable to take responsibility, work independently, and make decisions that balance quality requirements, authority expectations, and business needs. You describe yourself as pragmatic with a proactive mindset and excellent communication, collaboration skills and are fluent in English and Danish. About the department At CMC API Development, our goal is to create strong and dependable API processes for the entire Novo Nordisk drug candidate portfolio, with a focus on innovation, quality, and efficiency to improve the lives of patients. Our team is responsible for API process development, serving as the link between research and production. As the Quality Coordinator, you will join the Virology and Raw Materials department in Bagsværd, Denmark, and collaborate with all GMP-related departments in the CVP area, including virology, isotope technique, cell banks, and project office. The Virology and Raw Materials department consists of over 45 colleagues organized into three teams and is responsible for ensuring the virus safety of our API's and qualifying GMP materials for clinical production. Additionally, the Training Partner is also located in this department. While this position is primarily office-based, we offer flexibility to work from home when the tasks at hand allow. Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Director Kristine Buch Uldahl at +45 3077 5640. Deadline 29 March 2023 However, we will review applications and invite for interviews on a continuous basis. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. In addition, please avoid the use of photos in your CV. This makes for a better and more fair process. 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.
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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 11.3.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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