GLP and GCP Compliance Specialist

Are you passionate about utilizing your pre-clinical and/or clinical compliance knowledge? Do you wish to ensure quality assessment and deliveries during the Mergers & Acquisition (M&A) transaction phases?  Do you thrive understanding complex information to evaluate and summarize the overall Quality status of a potential asset in concise terms? Are you energized by interacting with many different stakeholders? 

If yes, then we want you to be our new Senior Compliance Specialist who will perform the Pre-clinical and Clinical Compliance assessment and recommendation as part of the Quality track of Due Diligences (DD)! Apply now to join our company and embark on a life-changing career!

The position
You will be part of Novo Nordisk Quality Due Diligence & Integration unit and act as a Pre-clinical and Clinical Compliance Specialist and as a trusted quality partner to the wider organisation in the due diligence phase. Depending on your background and expertise, your primary role will be to perform the needed quality assessment within the Good Laboratory Practice (GLP) domain and/or Good Clinical Practice (GCP) domain and prepare Quality recommendations for upper management. 

Among main tasks you will: 

• Drive and perform Quality DD assessment within the GLP domain and/or GCP domain
• Participate in internal Quality DD meetings to consolidate and align the Quality organisations position and the recommended integration strategies  
• Report DD recommendations and material for decision making, in close collaboration with other Quality Compliance Specialists 
• Review the contracts and transition agreements ensuring that the agreement reflect our position
• Support handover of DD outputs and recommendations to the Quality integration team

The job offers interaction across the organisation, allowing you to build a strong network. You will engage in defining steps ensuring a smooth, agile and transparent Due Diligence process. Furthermore, you will act as subject matter expert in your core area, keeping relevant stakeholders involved and informed and you will present findings and recommendations to management for endorsement.

Qualifications
We are looking for an ambitious and proactive colleague who can contribute to the team both professionally and personally. You structured mindset will support you in coordinating tasks, while you will combine strategic thinking with a strong quality and business understanding, to conduct and translate complex analysis into clear messaging.

To qualify for the position, you:

• Hold a master’s degree in science such as biology, pharmacy, biochemistry, virology, or similar
• Have a minimum several years of experience in a GLP and/or GCP area, e.g. in a Compliance and Quality Assurance role in Pre-clinical/Clinical Development
• Good understanding of drug development within the pharmaceutical industry
• Are fully proficient in English

If you have experience with Due Diligence or Integrations and have been a GLP/GCP auditor or a GLP/GCP inspector, that will be seen as an advantage.

As a person, you have strong organizational skills and attention to detail that enable you to maintain a comprehensive perspective on tasks and objectives, eve when facing changing circumstances, such as different working hours, deadlines, or project requirements.

You are a strong team player who enjoys delivering high-quality deliverables on short deadlines for senior management and key stakeholders, other than being solution-oriented with strong analytical and communication skills.

This allows you to demonstrate excellence in navigating complex situations involving multiple stakeholders.

As we operate globally, you should be willing to travel occasionally.

About the department
You will become part of a great department with many interfaces around the organisation; the Quality Due Diligence & Integration area is responsible for an efficient due diligence process in Quality of potential acquisitions. 

We drive integration activities in Quality, and finally we are responsible for maturing the M&A organisation and processes in Quality. You will have the exciting opportunity to take part in building the organisation and structure, as well as shaping the role we take in the M&A phases.  

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 50,000 employees. Together, we go further. Together, we’re life changing.

Contact
For further information please contact  Director, Bodil Rindel at [email protected]

Deadline
5 January 2025
 

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. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your resume. 

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.