Investigation Specialist

At the end of 2024, Novo Nordisk acquired the Catalent Anagni S.r.l. manufacturing site with the ambition of expanding our capacity to meet the needs of millions of patients. You will be joining a global team working on pharmaceutical plants that utilize advanced technologies within the site's fill & finish facilities.

At Novo Nordisk, we are proud to lead in innovation, ensuring the best quality in everything we do. If you're ready to be part of a dedicated team driving excellence, we are currently looking for an Investigation Specialist to join our dynamic team in Anagni!

The Position

As an Investigation Associate/Specialist, you will play a crucial role in executing critical and major investigations for both deviations and complaints. Working alongside Quality Assurance and other internal and external stakeholders, you will be responsible for identifying root causes, ensuring corrective and preventive actions are in place, and supporting regulatory compliance.

Additionally you will:

• Lead investigations for major deviations and quality events, working closely with Quality Assurance, SMEs, and other functions to assess interventions and ensure compliance with GMP guidelines and Novo Nordisk policies.
• Draft detailed investigation reports in English, including impact evaluations, corrective actions, and preventive measures, while verifying the execution and effectiveness of those actions.
• Serve as the internal point of contact for critical investigations, supporting the use of investigative methods and ensuring that root causes of deviations are properly addressed.
• Collaborate across the Novo Nordisk network, sharing best practices and aligning with corporate strategies while evaluating the feasibility of corrective actions, including environmental and safety impacts.
• Support audits and regulatory inspections, ensuring compliance with industry standards (GMP, ISO 13485, CRF 21 Part 111) and driving continuous process improvement.

This is a hybrid position, requiring 3 days per week on-site in Anagni.

Qualifications

To be successful in this role, we imagine that you have:

• A degree in Chemistry, CTF, Biology, Biotechnology, or Chemical Engineering (preferred).
• This position is open to candidates with at least one year of experience, though 3-4 years is preferred. Depending on your skills and experience, we will assess whether you are best suited for an Associate or Specialist level, with corresponding responsibilities.
• Strong command of the English & Italian languages, technical writing skills are a must.
• Solid understanding of statistical analysis and GMP compliance.
• Familiarity with pharmaceutical production processes would be considered a plus.
• Excellent communication skills, including the ability to listen, mediate, and openly share information.
• Enthusiasm for tackling challenges and continuous learning.

About the Department

You'll become part of a dynamic and close-knit team of 5 amazing individuals, working in an inspiring environment that celebrates teamwork and continuous learning! We foster a positive, inclusive work culture where every member’s impact makes a real difference. In this group, your skill will be valued, your ideas heard, and your personal growth supported.

Working at Novo Nordisk

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we

seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.

Contact

We can’t accept directly sent CVs, please submit your application via the ‘Apply’ Button.

Deadline

Apply before April 4th 2025.

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.