Quality Assurance Manager

Quality Assurance Manager & Deputy QP

**Category**:Quality

**Location**:Anagni, Lazio, IT
- End of 2024, Novo Nordisk acquired the manufacturing site Catalent Anagni S.r.l. with the ambition to expand our capacity to meet the needs of millions of patients. You will be part of a global team that will develop the pharma facilities of the future and work with advanced technology to rethink our fill & finish facilities.
- Are you passionate about ensuring the highest quality standards in the pharmaceutical industry? Novo Nordisk is seeking a dedicated Quality Assurance Manager and Qualified Person (QP) to join our dynamic team. In this role, you will play a pivotal part in guaranteeing compliance, enhancing quality systems, and driving continuous improvement. If you have a proven track record in quality assurance within a regulated environment and are ready to take on new challenges, we want to hear from you
- Elevate your career with us and make a difference in people's lives. Explore the opportunity today

**The Position**
- As a QA Manager and Deputy QP, you will play a crucial role in overseeing aseptic production activities and guarantee a high level of quality on products manufactured. You will assure complete compliance of batches to cGMP. In the role of Deputy QP, you will deal with all duties and responsibilities reported in EudraLex vol. 4 Annex 16.
- Furthermore, you will:

- Supervise QA activities to ensure compliance with regulatory standards and company policies across assigned departments.
- Oversee Good Manufacturing Practice (GMP) compliance in manufacturing and packaging processes.
- Support the Qualified Person (QP) in batch certification and release, serving as Deputy QP when necessary.
- Ensure inspection readiness and actively contribute to regulatory inspections.
- Revise and approve deviations, complaints, and liaise with stakeholders to plan quality assurance activities meeting customer needs.

**Qualifications**
- To thrive in this role, you have a bachelor's degree in a scientific field and a minimum of 5 years of QA experience in pharmaceutical companies, preferably in aseptic manufacturing. You are eligible or progressing toward Qualified Person (QP) status (EU Directive 2001/83/EC).
- In addition, you have:

- Extensive experience in GMP environments and a solid understanding of EU and international regulations.
- Excellent communication skills, with the ability to influence and collaborate effectively across all levels of the organization.
- Fluency in both English and Italian.
- Strong knowledge of manufacturing processes, product documentation, and quality procedures.
- Proven leadership and problem-solving abilities to effectively manage teams and projects.
- Autonomy in identifying and promoting quality improvement initiatives.
- Additionally, you should excel at building and managing relationships with peers, customers, and stakeholders to effectively balance various needs and priorities.

**About the Department**
- Our team is composed of enthusiastic, collaborative, and goal-driven professionals, each bringing a diverse level of experience and expertise. Every team member contributes to a dynamic and supportive environment where knowledge-sharing and mutual growth are central to our success. Known for their motivation, creativity, and commitment to maintaining the highest quality standards, our team thrives in a culture of continuous improvement by collaborating with the other departments (production, warehouse, laboratories, MST). Together, they work seamlessly, leveraging everyone’s unique strengths and experiences to achieve excellence and deliver exceptional results.

**Working at Novo Nordisk**
- We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

**Contact**

**Deadline**
- 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.