Quality assurance manager (50-80%)

LimmaTech Biologics AG is a Swiss clinical-stage biopharmaceutical company. We are advancing our proprietary vaccine pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance (AMR) and sexually transmitted diseases. Working at LimmaTech is a unique chance to be part of the development of life-saving vaccines.

We are currently looking for a highly skilled and motivated

Quality Assurance Manager (50-80%) to oversee and augment the Quality Management System (QMS) in our organization. The ideal candidate will ensure that all products and processes meet regulatory standards and internal quality requirements and drive continuous improvement in quality, efficiency and compliance.

You hold a life-sciences related degree and have at least five years of experience in quality assurance or quality control in the biotech environment. Demonstrated working experience in clinical stage biotech would be ideal.

As a Quality Assurance Manager, your responsibilities will include:

• Developing, implementing, and maintaining the QMS in accordance with applicable regulations and standards (e.g., FDA, EMA, ISO 9001, ISO 13485, GxP guidelines)
• Leading and performing internal audits and external audits of vendors, and organizing and serving as the primary contact during regulatory inspections
• Ensuring adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) where applicable
• Managing internal and external Corrective and Preventive Action (CAPA) programs
• Actively supporting department heads in identifying process improvements and their implementations
• Monitoring regulatory changes, updating organizational policies, and being responsible for the writing of policies, SOPs, and reports
• Providing training and mentorship on quality processes and regulatory requirements
• Overseeing document control, ensuring proper documentation of processes, procedures, and work instructions
• Fostering a quality-driven culture across the organization
• Promoting best practices in quality management to ensure alignment with industry trends and standards

You are an efficient and enthusiastic team player with:

• A degree in Biotechnology, Biology, Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or a related field
• Certifications in Quality Management, such as CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or ISO 9001 Lead Auditor (highly desirable)
• Hands-on experience in developing, implementing, and improving QMS of SMEs in the biotech field
• Demonstrating in-depth knowledge of regulatory requirements for FDA and EMA
• Ability to communicate complex information clearly to stakeholders at all levels with excellent communication and interpersonal skills
• Excellent attention to detail, analytical thinking and problem-solving skills
• Very good English skills (written and spoken)

We offer a friendly, highly motivated, multi-cultural, and dynamic work environment located in Schlieren, near Zürich. The location is easily accessible by public transportation.

If you meet the requirements of this exciting position and want to contribute to our mission, we would love to hear from you. Please submit your detailed application, including a motivation letter, CV, diplomas and reference letters as one PDF file. Incomplete applications will not be considered. Please apply directly via our website, choose the vacancy on the right-hand side and fill in the application form. Please press the “Submit” button to send your detailed application.

Please note that due to visa regulations, only applicants eligible to work in Switzerland can be considered for this position.