Quality Director

Quality Director

**Category**:Quality**Location**:Zurich, Switzerland Zurich, CH
- Are you passionate about quality, business acumen, and discovering smarter, more efficient ways of working?- Do you want to help shape the future of Quality at Novo Nordisk for the benefit of patients worldwide?- Are you ready to take on the responsibility of serving as a Quality partner to executive leadership and as the Quality Responsible Person (QRP)/Fachtechnisch verantwortliche Person (FvP)?- If so, this is a unique opportunity to join an ambitious, collaborative team where you will serve as the Quality Lead and QRP/FvP for Novo Nordisk Health Care AG (NNHCAG), the headquarters of the Novo Nordisk Global Rare Disease business unit**The Position**
- In this exiting position as our QRP/FvP, you will be the primary contact for Quality Assurance (QA) topics with customers and external bodies (e.g., Swissmedic) and responsible for the quality of distributed medicinal products (GMP/GDP).- You will also serve as the Quality Lead for the Rare Disease organization, as well as the Quality partner and strategic advisor to the executive leadership of the business unit. Your focus will be on securing our License to Operate, maintaining patient trust, and enabling GMP/GDP-compliant business growth.- Key responsibilities- **Inspection Readiness & Compliance**: Ensure compliance with national and international regulations, maintaining inspection readiness for operational license activities, and overseeing Quality Assurance processes, including handling product dispositions independently.
- **Quality Management System Maintenance**: Manage and maintain the Quality Management System (QMS), including GxP training, local quality records, and advising on internal and external regulations.
- **Leadership & Strategy**: Lead the development of the Rare Disease Quality strategy, Quality Management Reviews, and drive change projects to enhance processes and compliance.
- **Engagement in Key Initiatives**: Actively participate in key business initiatives that have GxP implications or involve patient safety, product quality, and compliance risks.
- **Deviations & Change Requests**: Oversee and approve deviations, change requests, and ensure appropriate action on rejected, recalled, falsified, or expired products, independent of Novo Nordisk or Rare Disease management decisions.

**Qualifications**- Furthermore:
- Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Medicine, Biology, or Microbiology; advanced degrees (e.g., Master's, PhD) preferred.
- Fluency in English is required, with proficiency in at least one of the following languages: German, French, Italian, or Romansch.
- Professional certifications (e.g., Lean Six Sigma, Quality Auditor) and membership in relevant bodies are advantageous.
- Knowledge of Swiss and EU GMP and GDP guidelines, as well as familiarity with international requirements (FDA, ICH, ISO).
- Experience with sterile manufacturing, biopharmaceuticals, and complex products (e.g., biologics, gene therapy) is highly desirable.
- Proficiency in risk management, compliance auditing, and strong knowledge of product development and manufacturing processes.
- Excellent problem-solving skills, attention to detail, decision-making ability, and strong project management skills.
- High ethical standards, integrity, and strong leadership with the ability to work cross-functionally and influence teams.
- Ability to handle pressure, work independently, and make critical decisions in line with regulatory requirements.

**About the Department**
- The Rare Disease business unit of Novo Nordisk is headquartered in Zurich, Switzerland, with hubs in Denmark, Turkey, India, and the US. We are focused on improving the lives of people with serious chronic rare diseases, placing patients at the centre of everything we do. Our vision is to be a leader in rare blood disorders and rare endocrine disorders.- We live by the Novo Nordisk Way and draw on the company’s rich heritage. Our working environment is entrepreneurial and fast-paced, and we are an ambitious team that values curiosity and generosity. If this spirit appeals to you, we may be the right place for you.- You will be part of a small but mighty team of five legal, compliance, and quality professionals spread across Zurich, Denmark, and Bangalore, India. The team is anchored in the Rare Disease business unit and reports directly to the executive leadership of the unit**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