Advanced QA Professional for Clinical Trials

Are you eager to play an important role in ensuring the quality and safety of products for [xxxxx] clinical trials? Are you ready to work with truly skilled and engaged colleagues? If so, we have an exciting possibility waiting for you as Advanced QA Professional and QP delegate in CMC Clinical Supplies QA.
The position
You will work with Quality Assurance for the Clinical Supplies area. This area is responsible for planning, labelling, packaging, and supplying products for [xxxxx] clinical trials run worldwide. With our stakeholders we play a crucial role in delivering products at the right time in the right quality and in the right quality to ensure patients enrolled in clinical trials can rely on [xxxxx]. The job has three key tasks:

Acting as a QP delegate certifying and releasing final packaged product from both [xxxxx] (NN) clinical packaging facility as well as from external contract manufacturing organisations.

Support our QP and handle cases of high complexity.

Support clinical packaging facility and processes around setting up and supplying products for clinical trials with tasks related to the Quality Management System.

Depending on your level of experience and ability to act across different subject matters, you will contribute to improvement projects both internally and across the NN Quality organisation. Supporting your personal development and ambitions is on your leader’s agenda from day one. Qualifications
To succeed in this role, you should:

Hold a Master’s degree in pharmaceuticals, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, or biology that fulfils the requirements to be a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen).

Preferably, have 2-5 years of experience from with quality or manufacturing within a pharmaceutical organisation with §39 authorisation. Knowledge within the area of clinical trial supplies will bring your CV to our immediate attention.

Possess excellent communication and collaboration skills.

Proficiency in English and Danish is required due to our international operations.

As a person, you are a self-driven person with a strong sense of responsibility and initiative. You excel at prioritising multiple tasks and thrive in a dynamic environment, where teamwork is on top of the agenda. Your ability to collaborate with many different stakeholders both internally and externally, is a key strength. About the department
You will become part of a department with 21 highly skilled and engaged colleagues. Every day we depend on our individual capabilities and our teamwork for living up to our high ambitions for delivering highest quality to patients. Our main purpose is to safeguard patient safety and ensure product quality and compliance in the CMC area. Working at [xxxxx] [xxxxx] 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. [xxxxx] 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 further information, please contact Nicolai Jørgensen on +[xxxxx]or Stephanie Hogrefe Nielsen on +[xxxxx].
Deadline
30 June 2024. We will review applications and conduct interviews continuously, hiring if the perfect match is found before the deadline. It might be you. We are excited to welcome our new colleague. 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 [xxxxx] 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.