Quality Director

Category: Quality

Location:Zurich, Switzerland Zurich, CH

• 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 Gx P 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 Gx P 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.

• Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Medicine, Biology, or Microbiology; advanced degrees (e.g., Master's, Ph D) 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.