We are looking for a highly motivated person for the role of a Quality Assurance (QA) Manager. The QA Manager will be responsible for quality assurance at Neurimmune with respect to clinical development activities in compliance with GxP guidelines as well as with applicable national and international regulations, corporate policies and Standard Operating Procedures (SOPs). This includes all QA aspects related to clinical development, including set-up and management of the internal quality management system, and management of QA aspects related to vendors (e.g. CMOs, CROs, clinical sites), as well as packaging, labelling, shipment, reconciliation and destruction of IMPs.
Responsibilities (include, but are not limited to):
- Establish and maintain Neurimmune’s overall Quality Management System and coordinate the preparation and/or revision of SOPs and Work Instructions
- Review existing and co-author new SOPs and Work Instructions with respect to GCP;
- Interpret GCP/GMP-related regulations/guidelines (ICH, EU, FDA, etc.) and translate them into company procedures and policies;
- Organize and lead audits at GCP vendors (e.g. CROs, clinical laboratories) including clinical study sites and participate in audits at other GxP vendors (e.g. CMOs, toxicology laboratories and other vendors);
- Plan, lead/participate in internal system audits including development of audit plans and tools, managing audit conduct, and reporting the results;
- Report to the management on the performance of the quality system and any need for improvement;
- Participate in cross-functional teams providing GxP advice and guidance on risk identification and risk-based approach in Quality Management;
- Review trial-related documents for consistency and compliance with appropriate standards;
- Coordinate the conduct of regulatory inspections, including inspection readiness and preparation, hosting/managing of inspections and any required follow-up activities;
- Set-up, maintain and manage the CAPA system to ensure timely remediation of quality incidents identified at Neurimmune, clinical sites and vendors, e.g. during monitoring, audits or inspections as well as spontaneously;
- Manage and perform Root Cause Analysis, evaluate suggested CAPAs and assess their effectiveness to ensure quality deficiencies are eradicated;
- Coordinate internal GxP training programs and maintain training documentation;
- Contribute quality compliance data for metrical analysis;
The candidate should maintain a work environment focused on quality, with respect, open communication, collaboration and teamwork and ensure all clinical trials are performed in compliance with SOPs, international and national applicable regulations. The role may require up to 25 % travel.
- At least 6 years of work experience in the biotechnology or pharmaceutical industry, with at least 2 years in a GCP compliance/QA role;
- Bachelor degree or advanced degree in a scientific or health-related discipline;
- Proficient knowledge and understanding of international, EU and US regulatory requirements related to GCP, GCLP and GMP (IMPs), with hands-on experience in clinical studies and documentation practices;
- Experience in performing or participating in internal and external GxP audits;
- Understanding of regulatory inspection processes is strongly preferred;
- Excellent interpersonal, verbal and written communication skills and problem-solving capabilities;
- Strong analytical skills and attention to detail;
- Flexible to work in a fast-paced small company environment with minimal direction and able to handle multiple demands with shifting priorities.
Neurimmune is committed to developing innovative treatments to improve the lives of patients. If you have relevant professional experience and would like to be considered for the position advertised, please forward your resume to:
Christine Frei, Human Resources Department,
Neurimmune AG, Wagistrasse 13, CH-8952 Schlieren.