Qualified Persons delegate, release of products for Novo Nordisk World Wide Clinical Trials

Category:  Quality
Location: 

Måløv, Capital Region of Denmark, DK

   

Novo Nordisk Quality, Research & Development

Denmark – Måløv

 

Do you thrive and perform at your very best with highly skilled and dedicated colleagues? Do you shine where you do your outmost to contribute to the success of the team? Do you master GMP and Quality related to packaging and supplying products for clinical trials? Do you demonstrate a high level of energy, motivation, and diplomacy. Then I may have just the right job for you in Clinical Supplies QA.

 

About the area

Novo Nordisk is going into new therapeutic areas. The portfolio is growing and diversifying as ever before. Volumes of patients, countries and sites participating in our clinical trials are increasing. Thus, we are seeking a new colleague in CMC Clinical Supplies QA to be part of this fantastic effort. We are part of the Novo Nordisk Qquality organisation where we enforce compliance on behalf of authorities and patients, support the business and at the same time strive towards making daily work for ourselves and our stakeholders less complex – always having the Novo Nordisk Quality Mission in sight: Highest Quality for Patients.

 

The job

Your will work as a QA for the Clinical Supplies area that are responsible for taking the clinical trials protocol into GMP operations i.e., setting up the trial with regards to products, labelling, packaging and distribution.

 

You will act as a QP delegate to certify and release the final packaged product prior to shipping out for clinical sites. You will work with your colleges in QA to constantly improve and simplify the way we work and support our stakeholders work with this as well.

 

We work at the borderline of GMP and GCP and you must be able to consider both aspects of regulations and reach out and obtain knowledge at this borderline. Regulations are evolving rapidly these years, so you must be able to adapt to and enjoy these changing times within your daily work.  

 

Depending on you level of experience and ability to act across, you will contribute to improvement projects both internally with our stakeholders, but also across the NN Quality organisation where we continuously strive towards taking our Q processes to the next level.

 

Qualifications

We are looking for candidates with

  • Masters degree in Pharmaceuticals, or other relevant area, living up to DKMA expectations for Qualified Person
  • Experience with production technologies and GMP related to the pharmaceutical industry, preferable manufacturing for clinical trials
  • Proficiency in oral and written English

 

You will work with multiple stakeholders across the organization and must have great stakeholder management skills and the ability to handle conflicting interests and evaluate issues from all perspectives. You must be able to take and communicate decisions in an effective way.

 

You must be structured, proactive, take responsibility and have a desire to contribute to the continual improvement of quality procedures, processes, and systems across the various units.

 

Good analytical skills with a balanced focus to attention to detail and seeing and evaluating the full picture are a requirement, since complex cases will have to be analysed and handled on a daily basis. The ability to work and deliver results independently and at the same time be a team player and make your colleagues shine is necessary.

 

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.

 

Contact

For clarifications or questions, please contact Birthe Rottwitt (+45 30750158)

 

Deadline

August 15th. I will look at applications and perform interviews continuously as we are eager to welcome our new colleague.

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.