Senior Quality Professional

5 days ago

Gentofte Kommune, Denmark Novo Nordisk AS Full time

Jobbeskrivelse
Placering
Gentofte, Denmark

Jobkategori
Quality

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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:

  1. Ensure smooth preparation and execution of on-site inspections in cooperation with stakeholders.
  2. Ensure timely coordination and support to authority requests.
  3. Develop and coach our internal stakeholders in FPM for inspection readiness.
  4. Support our FPM areas in internal audits.
  5. Never lose 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:

  1. You hold a master's degree in pharmacy, engineering, science or similar.
  2. You have experience from the pharmaceutical industry, preferably within production or QA.
  3. You are experienced in participating in GMP inspections from different health authorities.
  4. You have a flair for stakeholder management and networking at various organisational levels.
  5. 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.

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
If you want to know more about the position, please contact Associate Manager, Søren Tomra at +45 34 48 88 42

Deadline
22 September 2024.

Please note that applications will be reviewed continuously, and interviews will be planned as soon as suitable candidates have been identified.

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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