Senior QMS QA Professional
Køge, Region Zealand, DK
Are you passionate about ensuring quality processes and systems within a dynamic organization? We are seeking a motivated Senior QMS QA Professional to join our team. In this pivotal role, you will have a real impact on enhancing and maintaining our Quality Management System (QMS) to meet our strategic goals and regulatory requirements.
The position
In this position, you will play a key role in ensuring the effectiveness and compliance of our Quality Management System, which is vital for our growth strategy, while also driving a culture of quality throughout the organization by ensuring that all processes align with best practices and regulatory standards. Your main responsibilities will include:
- Quality Development: Collaborate with cross-functional teams to develop, review, and update SOPs that are clear, concise, and effective in practical application, while ensuring that this is in line with internal and external requirements.
- Process Improvement: Continuously assess and enhance our process landscape by identifying gaps and implementing structured review methodologies to ensure our processes meet best practices and regulatory requirements.
- Process Ownership: Serve as the owner of key quality processes, monitoring their performance, and ensuring that all stakeholders understand and follow them effectively across the organization.
- Internal auditor: Conduct internal audits to assess conformity with our QMS and identify areas for improvement.
- Audit host: Serve as host during customer audits at the site using your broad knowledge about quality to introduce key processes to the auditors and sustain the professional atmosphere during the audit.
- Training and Engagement: Organize and facilitate GMP training sessions, while actively participating in the QMS team to contribute to the overall enhancement of our quality management practices.
We offer an exciting and challenging position in an amazing department where focus on collaboration and team spirit is key. As a new member of the team, we will prioritize your training and support you in gaining the competencies needed.
Qualifications
We imagine that you have:
- M.Sc within Science, Pharmacy, Chemistry, Biotechnology or similar
- 5+ years of experience in the pharmaceutical industry preferably within QA
- Solid experience with QMS and process optimization
- Experienced internal auditor
- Full proficiency in Danish and English
On a personal level, you are a self-driven and strong team player with excellent problem-solving and communication skills; you are proactive and solution-oriented with a can-do attitude and strategic focus. Openness, honesty and focus on continuous improvements and quality mindset are natural parts of your personality and the way you work.
About the department
The team is a part of the QA/RA department at Novo Nordisk Pharmatech A/S. The QA/RA department currently consists of 30 employees working diligently to support the entire value chain, from Research & Development to Production and finally Sales & Marketing. We also cover quality and regulatory affairs related communication with the authorities, our B2B customers, our distributors, and our suppliers.
Working at Novo Nordisk Pharmatech
Novo Nordisk Pharmatech A/S has approximately 500 employees and is 100% owned by Novo Nordisk A/S. Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries, supplying products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds as well as raw materials for Novo Nordisk A/S. Novo Nordisk Pharmatech A/S is a growing company, which will provide many exciting projects in the future and good development opportunities in the job.
Contact
For further information, you can contact the Manager for QA Project Support and RA, Louise Vilstrup Thøgersen, on +45 3197 0235.
Deadline
18 April, 2025.
You do not need to attach a cover letter to your application, but you must include a few sentences about your motivation in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
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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.