Senior Quality Professional

2 weeks ago

Gentofte, Denmark Novo Nordisk AS - Nn1 Full time

Are you looking for a role that will enable you to use your strong quality mindset and great interpersonal skills to make a difference within Quality Assurance (QA)? Do you want to drive GMP (Good Manufacturing Practice) inspections to ensure the highest quality and safety of our products and for our patients? Are you eager to cooperate with some of our most experienced process experts, managers, and other stakeholders? 

If so, this position in Finished Products Manufacturing (FPM) QA would fit you. Read more and apply now for this exciting position 

The position 

You will be joining our FPM QA support team, and have the responsibility to plan, run and follow up on GMP inspections in close cooperation with the corporate inspection office and the manufacturing sites in Kalundborg, Hillerød and Gentofte. The inspections are conducted by a variety of health authorities and can be on-site, virtual or paper-based. Additionally, you will ensure adequate and timely responses to Regulatory Affairs (RA) requests and lead Pre-Approval Inspection (PAI) activities to obtain market access approval. We expect that you are ambitious, leading, and ready to be part of our ongoing effort to ensure a high degree of inspection readiness in FPM by: 

Ensure smooth preparation and execution of on-site inspections in cooperation with stakeholders. 

Ensure timely coordination and support to authority requests. 

Develop and coach our internal stakeholders in FPM for inspection readiness. 

Support our FPM areas in internal audits. 

Never loose overview and keep focus and engagement, despite changing priorities 

We are offering a job that provides a significant degree of influence, with responsibility and accountability as key components. This role requires excellent collaboration and time management skills. We are seeking a candidate who can set the direction and take the lead during the execution of inspections. During these inspections, you should be prepared to assist and guide our internal stakeholders, demonstrating adaptability to changing agendas. 


Furthermore, the position will involve various cross-organisational responsibilities, including roles related to quality processes throughout the organisation, among other duties. 

Qualifications 

Key qualifications are: 

You hold a master's degree in pharmacy, engineering, science or similar. 

You have experience from the pharmaceutical industry, preferably within production or QA. 

You are experienced in participating in GMP inspections from different health authorities. 

You have a flair for stakeholder management and networking at various organisational levels. 

You are fluent in both English and Danish. 

We are looking for a colleague with strong communication skills, who can create fellowship in the organisation also by being curious and robust. A proactive, self-starter attitude is highly valuable for us since you will have to take ownership of your own time and deliveries. 

About the department 

The FPM QA area is divided into six QA departments. You will be joining the Department of Local Manufacturing and Support QA. Specifically, you will become part of the QA Support team situated in Gentofte, which includes some of our most experienced business partners within LEAN, training, digitalisation, specialists and QA process managers. 

The team operates with a high level of self-governance, and our working relationships are informal. We value good humour and an open, honest culture. We appreciate colleagues who take responsibility and approach new challenges with positivity and curiosity. We believe that these qualities contribute to a great working atmosphere and are key to producing good results. 

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