In this position you will be responsible for the quality system and support in the oversight of quality-related processes to safeguard regulatory compliance as Numab expands clinical development with novel antibody fragment-based immunology and immune-oncology therapies. This role contributes to upholding the organization’s commitment to quality and compliance on a corporate level and specifically in our sponsored drug manufacturing and clinical development programs.
- Management and further development of Numab’s quality management system (QMS) and quality assurance program that supports the manufacture of clinical supplies and clinical development activities.
- Maintain validated state of the electronic QMS during systems updates and enhancements.
- Manage, monitor, and continuously improve Numab’s GxP quality system, by overseeing the QMS, training processes, records management, and service provider qualification.
- Contribute to managing the quality aspects of a network of service providers and collaboration partners to ensure compliance and project progress at required quality.
- Liaise with subject matter experts, both internal and external, from Project and Alliance Management, Chemistry, Manufacturing, and Controls (CMC), Drug Supply, Preclinical, Clinical Development, and Drug Safety to ensure the organization’s compliance with applicable GxP requirements.
Ideal candidates will have:
- Advanced life sciences' degree or equivalent qualification, with 3+ years of Quality Management or Quality Assurance experience at a biotech/pharma organization
- Solid understanding of drug development of biopharmaceuticals
- Strong understanding of major global (ICH, EU, US) regulatory compliance requirements
- Thorough knowledge of global GxP requirements for all phases of product development
- Working experience in maintaining and administrating a validated electronic QMS
- Hands on experience in GxP with a particular focus/expertise in GCP or GMP would be considered a plus
- Strong communication skills to address internal and external stakeholders with proven ability to work collaboratively
- Ability to prioritize, keeping the bigger picture in mind, and execute according to rigorous timelines
- Fluency in English as well as strong IT and organizational skills; fluency in German is considered a plus
What we offer:
- A diverse field of activity in a dynamic SME with an inspiring, entrepreneurial atmosphere
- Flat structures and fast decision-making
- The opportunity to take responsibility, help shaping and implementing solutions
- Employment conditions in line with the market, superior pension plan, flexible working time model, and opportunities for further personal development
- Regular bonus and participation in the employee stock option plan
- Participation in several fun team events
- A workplace near the city of Zurich overseeing the lake
We are looking forward to receiving your application with reference number NB113 to email@example.com.