Project Director for transforming asset and energy management at Parks and Recreation. Leading major change initiatives and ensuring compliance with applicable codes and standards.
About the role
- Quality lead and Responsible Person for the Rare Disease organization at Novo Nordisk. Engaging in quality assurance, compliance, and strategic leadership within an international healthcare setting.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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