Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders. The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action. Five of these compounds are currently in early clinical development with the three most advanced in clinical Phase II. The company has also been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.
Novimmune is seeking a a Clinical Quality Assurance Specialist, based in Basel, who will report to the Global Head of QA.
Clinical Quality Assurance Specialist
Key responsibilities and accountabilities:
To act as clinical QA representative and provide QA guidance to support the clinical organization in order to ensure compliance with GCP/GPV, and the clinical QA requirements
To implement and manage the clinical QA documents system, clinical QA systems, protocol deviation, investigations and change control. Ensure regular review of SOPs. Ensure tracking of CAPAs, and monitor effectiveness
To implement the internal clinical audit program, plan and perform the internal audits as well as to facilitate the CAPAs elaboration and follow-up, report the metrics
To participate in the clinical vendors qualification program, plan and perform audits of clinical vendors, follow-up the CAPAs, report the metrics
To QA assess sponsor, investigator and monitor compliance with protocol, GCP and clinical regulatory requirements
To ensure that all clinical staff are properly trained on SOPs and the industry guidelines and regulations. Develop clinical QA training program and materials and facilitate the training to clinical organization
To support the Inspection Readiness program, and support the preparation, coordination and management of regulatory sponsor inspections, and sites inspections. To facilitate the elaboration of CAPAs and ensure tracking and reporting
Skills and competencies:
Bachelor degree in biological sciences, chemistry, or related field
More than 8 years active experience in Clinical Quality program, setting Clinical SOPs, training, conducting and supporting clinical auditing & inspections programs
Practical working knowledge of GCP/GPV and all related EU & FDA regulatory requirements and ICH guidelines
Practical experience in conducting clinical audits of vendors, sponsor, prepare sponsor and investigation sites for EU and FDA Regulatory Inspections
Ability to work effectively in a fast-paced environment and work effectively as part of clinical organization team
Ability to take pragmatic approach to problem solving
Good verbal and written communication in English and in German or Italian will be an asset, and interpersonal skills.
Practical knowledge of Computer system validation
Ability to travel 20-30%, within EU and Internationally
Swiss resident or EU national
If your profile matches the above description, and if you are available at short-notice, please send us your CV and motivation letter in English.