QP delegate for Clinical Trials

QP delegate for Clinical Trials

Category: Quality Location: Måløv, Capital Region of Denmark, DK
Are you eager to play an important role in ensuring the quality and safety of products for Novo Nordisk clinical trials? Are you ready to work with truly skilled and engaged colleagues? If so, we have an exciting possibility waiting for you as QA and QP delegate in CMC Clinical Supplies QA. The position is based in Måløv, Denmark.

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 Novo Nordisk clinical trials run worldwide. With our stakeholders we play a crucial role in delivering products at the right time in the right quality to ensure patients enrolled in clinical trials can rely on Novo Nordisk. The job has three key tasks:

• Acting as a QP delegate certifying and releasing final packaged product from both NN clinical packaging facility as well as from external contract manufacturing organisations.
• Supporting our QP and in handling cases of high complexity.
• Supporting the 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:

• Your education must fulfil the requirements of a “Qualified Person” from the Danish Medicines Agency (Lægemiddelstyrelsen), requiring a Master’s degree in pharmaceuticals, medicine, veterinary science, pharmaceutical chemistry and technology, chemistry, or biology.
• Preferably, you 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.
• You are a self-driven person with a high sense of responsibility and initiative. You can prioritise many different tasks. You thrive in a dynamic environment, where teamwork is on top of the agenda. You like working with many different stakeholders – internally and externally.
• You possesses excellent communication and collaboration skills.
• We operate in an international company and the position therefore requires proficiency in English and Danish.

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 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 further information, please contact Nicolai Jørgensen (NQJ) on +45 30756335
Deadline
15 May 2024.
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.
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.