Novo Nordisk
CVP QMS Partner - CMC Development
Are you curious to use your quality knowledge, experience, and mindset in an exciting organization working with drug product formulation and implementation of analytical methods. Do you have a systematic approach and focus on details? Would you enjoy being responsible for keeping overview of our Quality and training?
If yes, then apply now and join us for a life-changing career!
The Position
As QMS Partner for our area you will be working to ensure a high level of quality and compliance, by setting the right standards in maintaining our Quality Management System so that we continuously deliver on all relevant GMP requirements while at the same finding the right balance where GMP to the highest standard is not required. The same approach will be relevant when you ensure that the right training system is in place. Also, you will have the opportunity to develop and improve the way we work with quality.
Additionally, you will be responsible for a the QMS group where you will head up a group of great colleagues working within the department, across our CVP area.
You will be responsible for:
Ensuring high-level GMP overview and report quality trends to management.
Driving preparation for, participate in and follow-up on authority inspections and internal audits
Responsible for the Quality Management Review (QMR).
Supporting daily operations and ensure the relevant level of GMP and training
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
As part of your responsibilities, you will run compliance projects in the department and conduct the training of new employees in GMP.
Finally, you will be work out of the DP & Analytical Development Office and will join a harmonious department with competent, caring, and positive colleagues. We have a strong foundation of employees with high seniority mixed with more recent newcomers.
Qualifications
Master's degree in pharmacy, biochemistry, production engineering or similar
At least 5 years of GMP experience from the pharmaceutical industry (manufacturing/QC/QA)
Strong understanding of GMP regulations and requirements
Excellent communication and interpersonal skills
Ability to work independently with a pragmatic mindset
Experience with project management
Preferably cLEAN certified
Ability to manage multiple projects and priorities
Full professional proficiency English, Danish is an advantage, but not required.
On a personal level you thrive and get motivated by working with and across all levels in the organization, whilst you enjoy great collaboration and communication and setting direction. Additionally, you are solution oriented and work systematically with a pragmatic approach and strive for simplicity in processes.
About the department
As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. CMC Drug Product and Analytical Development (DP & Ana Dev), we turn molecules from early research into approvable products ready for the market. In DP & Ana Dev, we develop, document and supply drug products, manufacturing, processes, analytical methods, and analytical results. We are an ambitious organization with a strong culture. We constantly challenge and question the existing processes and identify new opportunities to solve problems. We do our best to deliver despite any obstacles along the way.
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