Quality and Compliance Project Manager
4 weeks ago
Do you want to be part of Novo Nordisk and help expand our position as one of the most innovative and successful pharma companies? Would you like to help support production in ensuring the right level of Quality and continuous improvements? Do you enjoy managing larger compliance projects across multiple departments with many stakeholders, and does inspections and audits excite you? Then we can offer you an exciting position, where your quality mindset and expertise in leading planned and incoming compliance projects while supporting the ongoing needs in your own department with your in-depth GMP/QMS knowledge will be extremely valuable for us as a company, reaching our ambitious goals while having the right level of quality. Apply today for a life-changing career
The positionThis critical position involves managing complex quality and compliance projects, from planning through implementation, to ensure we meet the highest standards. It is an exciting and challenging role with a wide variety of tasks and many stakeholders across multiple departments and larger projects across different CVP areas. You will play a key role in project management within the quality coordination team, ensuring successful delivery while maintaining compliance.
Key tasks:
- Assist in scoping and prioritizing incoming compliance signals from various audits and inspections
- Manage and ensure plan adherence in planned and incoming compliance improvement projects
- Identify trends and possibilities for improvements that can reduce complexity and build quality and robustness into the processes
- Prepare for internal audits and inspections
- Ensure change management when implementing improvements to GMP and QMS
- Prepare trend reports, quality oversight tools, Quality Management Review, etc.
To succeed in this job, it is a prerequisite that you have a can-do attitude, are curious to understand, gain energy by interacting with many stakeholders, and thrive in managing different tasks simultaneously.
QualificationsThe position requires a high degree of knowledge within working with compliance improvements in a GMP regulated environment and the ability to scope and deliver the best-possible solutions to new requirements from signals, inspections, and audits.
Furthermore:
- You have a minimum of 5 years of experience with GMP from a relevant position in the medical industry, complemented by the ability to manage complex projects.
- You hold a master's degree within chemistry, life sciences, or another relevant field.
- You have experience with most of the following processes: deviation handling, change requests, qualification/validation, QC/EM procedures, and compliance project management.
- You are curious and able to see opportunities for compliance improvements. Independence is a prerequisite, as well as the ability to collaborate with various groups of employees with different backgrounds.
- You speak/write professionally in English.
You will be reporting to the Department Manager and be a part of the management team of QC/EM (Quality Control/Environmental Monitoring) in M1. However, the majority of your time will be spent on prioritizing and managing larger cross-departmental compliance projects in close collaboration with the rest of the quality coordinator group in M1. The group consists of five highly dedicated and qualified persons with whom you will solve most of your cross-departmental tasks in collaboration with. We share an informal and relaxed tone and work purposefully to deliver the right level of quality of our products to the patients we serve every day.
About Novo Nordisk KalundborgBecome a part of Novo Nordisk Manufacturing in Kalundborg and get a developing career among the most talented people in a successful company. Together, we make a real difference every day for more than 30 million people living with diabetes and other chronic diseases. We have 50 years of expertise in biotechnological production at Novo Nordisk in Kalundborg. Generations of employees have developed their professional qualifications, personal skills, and careers at Novo Nordisk and have helped develop the production facility to become the largest insulin-producing facility in the world. Today, our 3,000 employees produce half of the world's insulin and a number of biopharmaceutical products. Furthermore, our finished product sections assemble and pack diabetes and biopharmaceutical products. You will soon sense why Novo Nordisk Kalundborg is a highly unique place and why we are passionate about working here. You will be met with trust and responsibility by welcoming and dedicated colleagues. Novo Nordisk Kalundborg is a workplace where involvement, development, and multi-disciplinarity are in focus.
ContactIf you have any questions regarding the position, please feel free to contact Annika Jensen at 30750856 or CVP Quality Coordinator Mikkel Størling at 34486668.
Deadline8 April 2025
Please note that we will be reviewing applications on an ongoing basis.
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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