Senior software tester állások Külföldön (minőségbiztosítás)

Senior Expert Regulatory Affairs - CMC/BiosimilarsShape CMC regulatory strategy for complex biologics in a fast-growing biotech environmentFor a fast-growing, internationally active biotech company focused on biosimilar development, we are currently looking for a Senior Expert Regulatory Affairs...

Senior Industrialization Project ManagerDesign the machines that build the future of medical technologyBased in the Neuchâtel canton, our client is a highly innovative Swiss MedTech company with nearly 100 years of precision engineering expertise. Recognized worldwide for the quality of its...

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

Quality Manager Global BiopharmaSteriles - QA Operations - CMO ManagementAre you an experienced Quality Operations professional (m/f/d) looking to take ownership in a global external manufacturing environment? Our client is seeking a motivated Quality Operations Manager to provide quality oversight...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Development Operations Manager (ATMP) (Geneva, CH | 80%-100% FTE | Hybrid/Remote Possible)About the CompanyRelease Therapeutics SA is a Switzerland-based biotechnology company developing an Advanced Therapy Medicinal Product (ATMP) program in the CNS and beyond. We operate with a very lean internal...

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...