QMS Specialist for Brownfield Quality Operations
1 day ago
Category: Quality
Location: Bagsværd, Capital Region of Denmark, DK
Are you passionate about quality management systems? Do you thrive in dynamic environments where you can make a significant impact? We are seeking a QSM Specialist to join our Brownfield Quality Operations department at Novo Nordisk. If you are ready to take on a challenging role and drive quality improvements, read more and apply today for a life-changing career.
The position
As a QSM Specialist, you will play a crucial role in maintaining the Brownfield part of the Quality Management System (QMS), ensuring it meets compliance standards and is always ready for inspection. You will support daily QMS operations by managing the cross-site quality processes, ensuring the appropriate level of compliance with requirements and authority expectations to Good Manufacturing Practice (GMP) and training is upheld. Additionally, you will provide valuable input to the System and Product owners for the IT systems owned by the Brownfield Quality function. Your responsibilities will include overseeing the Quality Management Review process across the Brownfield organization and driving quality and process improvement initiatives to support harmonization across the three sites.
Main tasks include:
- Ensuring compliance and inspection readiness of the Brownfield QMS.
- Management of cross-site Quality Processes.
- Supporting daily QMS operations and maintaining GMP standards.
- Providing input to IT system owners within the Brownfield Quality function.
- Overseeing the Quality Management Review process.
- Driving quality improvement and harmonization initiatives across sites.
As our headquarter is based in Denmark and the sites are in Europe and the US, there will be some travel expected, varying from 10% to 30%.
Qualifications
We are looking for a candidate with:
- A master's degree in pharmacy, biochemistry, production engineering, or a related field.
- Over 10 years of experience working in complex, high-pressure environments, with comprehensive knowledge and a full understanding of current Good Manufacturing Practices (cGMP) as well as all relevant laws and guidelines.
- Experience from operating quality systems is essential as is knowledge of quality audits, quality assurance, quality control, and ISO standards/cGxP.
- Experience with authority inspections.
- Fluency in English, both spoken and written.
As a person, you possess strong change management and communication skills that enable you to navigate complex situations effectively. Your cultural understanding and intercultural communication abilities allow you to connect with diverse individuals and foster collaboration across varying backgrounds. With high personal integrity, you approach challenges in a structured and analytical manner, ensuring that decisions are well-informed and thoughtful. You thrive both independently and as part of a team, where you excel at building relationships and establishing trust at all organizational levels, contributing to a positive and productive work environment.
About the department
You will join the Brownfield Quality Operations unit, where we focus on integrating acquired manufacturing sites into Novo Nordisk's quality system. Our team is dedicated to ensuring a seamless transition and maintaining high-quality standards across all sites. We are based in a dynamic and collaborative environment, working closely with various stakeholders to achieve our goals.
Working at Novo Nordisk
At 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 to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
Contact
If you wish to know more about this position, please contact Morten R T Nielsen, Director at +45-30798952.
Deadline
17 March 2025. Interviews will be conducted on an ongoing basis, so we encourage you to apply as soon as possible. Relevant candidates may be interviewed before the deadline.
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 the communities we operate in. Together, we're life-changing.
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