Advanced QA and QP Delegate for Clinical development batches

Category:

Quality

Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so, then this position as QA Professional/QP delegate can be an exciting possibility for you as we are expanding.

CMC Development makes a difference for patients with chronic diseases across the world and the organisation develop, manufacture, and distribute drug candidates for clinical trials.

CMC Development/CMC QA is an ambitious organisation with a strong culture, that always seek to solve problems, have an eye for the entire business and do the best to deliver despite any obstacles along the way. We have a high focus on delivering high quality to our customers which is why we are looking for a dedicated and experienced QA to take an active part in securing our quality level.

The job

As a QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability, and status assignment of clinical batches produced in CMC and PS. In addition, you will be a part of our development projects ensuring our products used in clinical trials are following the information provided to Health Authorities worldwide.

We have a job opening in both Måløv and in Bagsværd as the department covers both sites and we have shared training, meetings, and activities across the department. Furthermore, a few yearly travel days can be expected when working with our international Contract Manufacturing Organisations (CMO) where we are producing clinical batches as well. If you are skilled in aseptic manufacturing processes pre-assessments and audits of new CMO´s can also become a part of your job.

Qualifications

You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar and fulfil the requirements from the Danish Health Authorities to become QP delegate. You have experience with GMP and quality assurance - preferably within batch release/status assignment. Experience with activities in (aseptic) production and/or QC is an advantage.

The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems.

You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity.

You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders.

As we operate both in a national and an international environment, you must speak and write Danish and English fluently or are in the process of taking Danish courses on a high level.

About the department

You will become part of a department consisting of three teams where we currently are more than 35 dedicated colleagues. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicines to patients.

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.

Contact

For further information, please contact Marianne Mørch Hansen +45 3079 8154.

Deadline 19th April 2024

Applications will be screened on an ongoing basis, and interviews conducted continuously. We will take the opportunity to close the position as soon as we find a match. Hence, you are encouraged to apply now.

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 communities we operate in. Together, we’re life changing.

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.