Pre-clinical Compliance Specialist

Are you passionate about utilizing your pre-clinical compliance knowledge? Do you wish to ensure quality assessment and deliveries during the Mergers & Acquisition (M&A) transaction phases? Do you thrive on 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 pre-clinical Compliance Specialist who will perform the Good Laboratory Practice (GLP) compliance assessment and recommendations 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 Compliance Specialist and quality partner to the wider organisation in the due diligence phase, where your primary role will be to perform the needed quality assessment within the GLP domain and prepare Quality recommendations for upper management.
 

Among main tasks you will: 
• Drive and perform Quality DD assessment within the GLP 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 masters’ degree in science such as biology, pharmacy, biochemistry, virology, or similar
• Have a minimum several years of experience in a GLP area, e.g. in a Compliance and Quality Assurance role in Pre-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 auditor or a GLP 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.