swisselect, leading in life science recruitment in Switzerland
On behalf of our client, a growing bio-pharmaceutical company specialising in the treatment of rare diseases, we seek a
Clinical Quality Assurance Manager
Acting as the Clinical Quality Assurance interface in order to provide guidance within the clinical organization, ensuring compliance with GCP and GPV.
Your responsibilities include the maintenance and supervision of the clinical QA documents system, clinical QA systems as well as protocol deviations, investigations and change control.
Tracking CAPAs related to audit, report metrics and monitor effectiveness. Facilitation of the CAPAs elaboration and follow-up metrics.
Training of clinical staff on SOPs, industry guidelines and regulations. To ensure that clinical QA training program and materials are compliant and facilitate the training to clinical organization.
Support the inspection readiness preparation, coordination and management of regulatory sponsor and study site inspections.
Bachelor degree in biological sciences, chemistry, or related field
5 years + active experience in Clinical Trials monitoring or Clinical Quality program, and training, CAPAs
Practical working knowledge of GCP/GPV and related EU & FDA regulatory requirements and ICH guidelines
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
Business level English is a pre-requisite, German or Italian would be an asset
Please provide your application documents to us via our online portal. All applications will receive a feedback. For any further questions, please do not hesitate to contact Dr. Louise Duerr who can be reached at firstname.lastname@example.org*
* With reference to the new General Data Protection Regulation, valid per 25 May 2018, we require your written consent in order to process and store your personal data. Your consent applies to the application procedure with swisselect group. Please note that you can revoke your consent at any time.