Novo Nordisk

Associate Director, Quality, Responsible Person

Novo Nordisk

full-time

Posted on:

Location Type: Office

Location: Zurich • Switzerland

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Job Level

Senior

About the role

  • 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)
  • Serve as the Quality lead for the Rare Disease organization and Quality partner and strategic advisor to the executive leadership of the business unit
  • Focus on securing our License to Operate, maintaining patient trust, and enabling GMP/GDP compliant business growth
  • 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
  • Ensure Quality Assurance related compliance with all National and International Regulations (e.g. MPLO, Cantonal Laws and Regulations etc.) and internal regulations
  • Decide independently on disposition of rejected, recalled, falsified and expired products.

Requirements

  • Educational background degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Medicine, Biology, Microbiology; advanced degrees (e.g., Master's, PhD) preferred
  • Professional certifications (e.g., Certified Lean Six Sigma, Quality Auditor) and membership in relevant professional bodies can be an advantage
  • 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
  • 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
  • Fluency in English
  • Proficiency in German required, French, Italian, or Romansch is an advantage.
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development opportunities
  • Health insurance
  • Retirement plans
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceGood Manufacturing Practice (GMP)Good Distribution Practice (GDP)Quality Management SystemDeviations and Change RequestsQuality Management ReviewPharmaceutical regulationsSterile manufacturingBiopharmaceuticalsComplex product types
Soft Skills
LeadershipStrategic advisingProcess improvementCommunicationOrganizational skillsCollaborationProblem-solvingChange managementQuality understandingInspection readiness
Certifications
Certified Lean Six SigmaQuality AuditorPharmaceutical Sciences degreeChemistry degreeBiochemistry degreeMedicine degreeBiology degreeMicrobiology degreeMaster's degreePhD