(Senior) Inspection Coordinator, QA

Are you looking for a role that will enable you to use your strong quality mind-set 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 Biotech & Rare Diseases (BRD) QA would fit you. Read more and apply now for this exciting position! The position
You will be joining a small team of three and your main responsibility will be to plan, run and follow up on GMP inspections in close cooperation with the corporate inspection office and the manufacturing sites in Bagsværd, Hillerød, Kalundborg, 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 Inspections (PAI) activities to obtain market access approval.
We expect that you are ambitious, leading, and ready to be part of our on-going effort to ensure a high degree of inspection readiness in BRD by:
• Coordinate and support authority requests
• Executed timely ensuring the highest quality to patients.
• Efficiently sharing expertise within the organization
• Set direction and deliver results in an environment that fosters innovation and creative thinking built upon a solid setup.
• Never lose focus or engagement, despite changing demands
We offer a job where you have a large degree of influence where responsibility and accountability are key ingredients, and where we strive to continuously learn and improve our processes.This demands good collaboration and time management skills, and a solution-oriented approach when collaborating with colleagues both in ManDev, production, QC and QA. Furthermore, the position will cover other cross-organizational tasks within quality such as Quality Management Review, process roles etc. If you are new to the roles as inspection coordinator, we will provide you with strong guidance and training. Qualifications
Key Qualifications are:
• You hold a master’s degree in pharmacy, engineering, science or similar.
• You have experience from the pharmaceutical industry preferable within production or QA.
• You have flair for stakeholder management and networking at various organisational levels.
• You are fluent in English, and speak Danish with high proficiency.
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 BRD QA area comprises 275 employees and is divided into six QA departments. You will be joining the Department of QA for QC, MDev, and Business Support located in Gentofte. Specifically, you will become part of the Business Support team, which include some of our most experienced business partners and 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 [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
If you want to know more about the position, please contact Associate Manager, Søren Tomra at +[xxxxx]
Deadline
21 April 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 t o 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.