Senior QMS Professional - Måløv, Danmark - Novo Nordisk A/S - A1p

Beskrivelse

The position In Drug Product & Analytical Development Project Office, we are responsible for the analytical and drug product development for both early and late phase clinical trials, submission and much more. You will be a part of a small but growing group of skilled individuals, working to support 20+ analytical project managers. You will be the first with QMS experience, as primary skillset, and you will get the opportunity to impact our way of working with QMS processes. It will be your responsibility to support our analytical project managers on various GMP and documentation related tasks to ensure that the required product quality is achieved and consequently secure the safety of our patients.


You will:
Implement change requests, e.
G. For new/updated product specifications. Handle quality related tasks, such as SOP reviews/updates. Take part in CMO collaborations incl. Site audits/visits and document flow management. Collaborate with colleagues from other parts of CMC and manufacturing development, quality assurance and regulatory affairs. Take part in/lead standardising and optimising above mentioned tasks/processes. Furthermore, and depending on your qualifications and motivation, you are likely to be involved in regulatory documentation processes.


Here assignments could include:

write and review regulatory submission documents such as CTA (Clinical Trial Applications) and marketing applications related to the analytical field.

take part in the process of answering questions from health authorities across the globe related to our submissions. take part in giving content to the way we write our regulatory documents based on continuous learnings and feedback.

To succeed in this role, you will take ownership and have a proactive approach and close cooperation with colleagues in the Project Office and analytical departments, ensure that our setup and documentation is in order and that required product quality and compliance is achieved.

Qualifications We are currently looking for a colleague with experience from a quality related position, ideally combined with analytical development, as well as a Master's degree within Pharmacy, Chemistry, Engineering, or a similar field.

To be successful in this role, the following qualifications are relevant:
Strong knowledge and experience in quality management systems from pharmaceutical industry. Experience in writing and driving change request with many stakeholders. Familiarity with auditing, monitoring, and determining the quality of processes. Excellent attention to detail and ability to identify recurring problems. Good communication and collaboration skills. Experience with documents such as Justification of specification and product specifications. You have a structured and detail-oriented approach to everything you do.

You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills.

On a personal note, you are open-minded, enjoy sparring and great colleagueship.

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.

Your new department, CMC Drug Product Development

• Project Office, consists of 50 employees located in Måløv.

The department is involved in early and late-stage drug product development, analytical development and chemical and biological characterization of new entities moving through the clinical phases of drug product development. 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, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.