Senior GMP Coordinator

Do you have a passion for Good Manufacturing Practice (GMP), and are you motivated by setting the compliance direction and ensuring that we continuously improve our processes and ways of working? Do you get energy from having a large contact base, being part of the management team, and the possibility to work with highly qualified colleagues within your field?

Then you might be our new Senior GMP Partner! Apply today and join us for a life-changing career.

The position
As Senior GMP Coordinator you will work closely with the management team and the local GMP coordinators. You will be responsible for supporting management and colleagues across the site in maintaining and developing a high GMP level. You will be positioned in Business Support and report to the director.

The position is characterized by a dynamic mix of coordination, follow-up and participation in management related activities and execution of your own tasks in a more focused manner.

Your tasks will include:
• Drive preparation for and follow-up on authority inspections and internal audits
• Ensure high-level GMP overview, and report quality trends to management
• Lead and coordinate critical quality issues and compliance activities, where cross site coordination is necessary
• Coach and assist your colleagues in GMP related tasks such as deviations and changes (delimitation, corrective & preventive actions, qualifications, etc.)
• Coach and facilitate cLean related task such as systematic problem solving or continuous improvements

In addition to this, you will have the GMP Coordinator responsibility for Business Support. You will be part of the GMP networks within the area, and in corporation with your peers in the other departments address tasks and challenges that reach across the areas, such as inspection preparation, implementation of new systems or procedures etc.

Qualifications
To succeed in this role, you have:
• An academic degree within pharmacy, chemical engineering, chemistry/biology or similar
• Extensive experience from the pharmaceutical or medical device industry or similar related areas
• Knowledge within complex production processes and have experience from GMP regulated areas
• Experience as GMP Coordinator for 2-3 years
• Full professional proficiency in Danish & English

As a person you are positive, corporative, action and solution orientated, and you work systematically, logically, and proactive. It’s important that you can think and act with a broad and holistic perspective, seeing the big picture without losing sight or interest in important details.

You are a people person who can interact and communicate at all levels of the organisation, from operator to management, and you take pride in solving your tasks and challenges as close to the process as possible, with close involvement of your key stakeholders. You take initiative and to ensure commitment from your stakeholders, you have great focus on change management when introducing your ideas.

About the department
Biotech & Rare Disease (BRD) Finished Products Kalundborg is part of our largest production complex in Novo Nordisk. Here we are app. 520 colleagues who take responsibility for transforming Active Pharmaceutical Ingredients into the finished product that patients can use all over the world. We rely on our stabile/well-run/best-in-class packaging department and our newly established high-tech and high-volume filling facility. Our complex processes require a high level of expertise, commitment, and engagement from our employees and include formulation, filling, freeze-drying, product inspection, assembly, and pack. We bring value to patients by delivering high-quality Good Manufacturing Process (GMP) compliant products in a timely and cost-efficient manner. We drive change by working actively with LEAN and always looking for improvements within our processes but also in the way we work together to make our products reach as many patients as possible.

Working at BRD, Novo Nordisk
Biotech & Rare Disease (BRD) is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD we are not only supplying all Novo Nordisk products for Rare Diseases, but also using our competences in Biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk. We are app. 2650 colleagues committed to drive change for people with serious chronic diseases. We produce our life-saving medicines out of five state-of-the-art production sites in Denmark and United States - covering the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. Not only are we making a difference for patients – we also strive to make a difference for our employees by promoting a learning culture with high level of trust, innovation, and development for everyone. Are you ready for a life-changing career?

Contact
If you want to know more about the position, please reach out to Business Support Director Sara Gärtner Krag-Jensen at 30 75 94 99.

Deadline
4 December 2022.

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.

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