Numab Therapeutics AG is an expanding, clinical stage Swiss biotech company based in Wädenswil, Kanton Zürich. The company is focused on the discovery and development of innovative, antibody fragment-based therapeutics with a focus on immuno-oncology. With our breakthrough antibody-discovery and multi-specifics engineering platform, we engage in proprietary projects as well as collaborative research on behalf of partners in the pharmaceutical industry.
Oversee and develop Numab’s Quality Management System and to ensure adherence to internal processes and regulatory requirements, we are looking for a
Head Quality Assurance 100%
In this position you will report to the Chief Operating Officer and you will be responsible for overseeing quality-related processes to safeguard regulatory compliance as Numab expands clinical development with novel antibody fragment-based immuno-oncology therapies. This role principally 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.
- Provide strategic direction and leadership for the development and execution of Numab’s quality assurance program that supports the manufacture of clinical supply and development activities
- Manage, monitor and continuously improve GxP quality systems, by overseeing the QMS, training processes, records management and vendor qualification using key performance indicators
- Liaise with subject matter experts from CMC, Preclinical, Clinical Development and Drug Safety to ensure the organization’s compliance with applicable GxP regulations
- Manage the Quality aspects of a network of suppliers and co-development partners to ensure compliance and project progress at required quality
- Provide strategic expertise to executive leadership and project teams on quality matters
Ideal candidates will have
- Advanced degree in the life sciences or equivalent qualification, with 10+ years of Quality Assurance experience, at least 5 of which must have been in a leadership role within a Quality unit at a biotech/pharma organization.
- Comprehensive 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 through commercialization, with particular focus/expertise in GMP aspects
- Experience in planning and participating in internal and external audits and regulatory agency inspections
- 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
Are you looking for an inspiring, entrepreneurial atmosphere and want to be part of a dynamic team where your contributions are both essential and valued? We are looking for skilled people who are eager to make an impact. We are offering a permanent position in an innovative environment as well as a competitive compensation package including a participation in the company.
We are looking forward to receiving your application with reference number NB062 to Click to send email.