Associate Director, Quality and Quality Responsible Person (FvP)

Associate Director Quality and Quality Responsible Person/Fachtechnisch verantwortliche Person (FvP) Novo Nordisk Health Care AG Rare Disease Operations

Are you passionate about quality business understanding and finding smarter better ways to work Do you want to shape the future of Quality in Novo Nordisk for the benefit of our patients across the world Are you ready for the responsibility of serving as Quality partner to executive leadership and as Quality Responsible Person (QRP)/Fachtechnisch verantwortliche Person (FvP)

If so this is a unique opportunity to join an ambitious collaborative team in which you will be Quality lead and QRP/FvP for Novo Nordisk Health Care AG (NNHCAG) headquarters for the Novo Nordisk Global Rare Disease business unit.

About the organizationand team

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. Patients are at the centre of everything we do. Our vision is to be a leader in rare blood disorders and rare endocrine disorders. We live the Novo Nordisk Way and draw on the companys rich heritage. Our working environment is entrepreneurial and fast-paced and we are an ambitious team that values curiosity and generosity. If this spirit is appealing to you then we may be the right place for you.

You will be part of a small but mighty 5-person team of legal compliance and quality professionals spread out over Zurich Denmark and Bangalore India. The team is anchored in the Rare Disease business unit and reports directly to the executive leadership of the business unit.

The Position

As QRP/FvP you will be the main contact on Quality Assurance (QA) topics to 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 and 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:

• Ensure Inspection readiness of the applicable Operational License activities
• Maintain the Quality Management System including GxP training and local quality records
• Mature the NNHCAG/Rare Disease Quality strategy and lead change projects
• Lead Quality Management Review and engage in process confirmations to identify process improvements
• Advise organization on Novo Nordisk Quality Management System and external regulations
• Foster Quality understanding in the organization
• Engage in key business initiatives with GxP implications or major risk to patient safety product quality and compliance
• Handle and approve Deviations and Change Requests

As the QRP/FvP according to the Swiss Medicinal Products Licensing Ordinance and the Swissmedic Technical Interpretation you will:

• Have the authority to issue directives and to take decisions with regards to their responsibilities independently of Novo Nordisk Management and the Rare Disease management team.
• Ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO Cantonal Laws and Regulations etc.) and internal regulations.
• Decide independently of Novo Nordisk Management and the Rare Disease management team on disposition of rejected recalled falsified and expired products.

The position is based in Zurich.

Qualifications

1. Educational background

• • degree in Pharmaceutical Sciences Chemistry Biochemistry Medicine Biology Microbiology; advanced degrees (e.g. Masters PhD) preferred
  • Professional certifications (e.g. Certified Lean Six Sigma Quality Auditor) and membership in relevant professional bodies can be an advantage

1. Regulatory Expertise:

• • Knowledge of Swiss and EU Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines
  • Familiarity with other international requirements e.g. FDA regulations ICH guidelines and ISO standards
  • In-depth understanding quality systems and pharmaceutical regulations

1. Experience:

• • 5-10 years in pharmaceutical manufacturing quality assurance or quality control with several years in a supervisory or QA/QP role
  • Experience in a global or multi-national pharma or biotech company
  • Experience with sterile manufacturing biopharmaceuticals and complex product types (e.g. biologics gene therapy) is highly desirable

1. Skills:

• • Proficiency in risk management and compliance auditing
  • Strong knowledge of product development manufacturing processes validation and batch release procedures
  • Excellent problem-solving skills attention to detail and decision-making ability
  • Strong project management skills and ability to execute in a complex fast-moving environment

1. Personal Attributes:

• • High ethical standards and integrity
  • Strong leadership stakeholder management and communication skills 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
  • Proactive attitude and high level of initiative in anticipating challenges and opportunities and actively seeks out ways to improve processes
  • Pragmatic solution-oriented approach and sense of business partnership
  • Commitment to ongoing professional development and keeping up-to-date with changes in regulations guidelines and industry best practices

1. Language Skills:

• • Fluency in English
  • Proficiency in German required French Italian or Romansch is an advantage

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. Thats 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 its a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 60000 employees. Together we go further. Together were life-changing.

Deadline

26 March 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.