Hobson Prior are looking for a Quality & Compliance Manager for Clinical Studies to join a rare diseases company on a permanent basis. This organisation is focused on accelerating the development of new drugs.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for any quality and compliance topic related to the Clinical Studies Department.
• Strong contribution to the communication and training of SOPs to operational teams.
• Overseeing overall Clinical Studies Department's quality and training compliance.
• Develop, establish, maintain, revise and adapt Clinical Studies Department related SOPs, processes, user manuals and work instructions to ensure systematic quality assurance.
• Provide daily quality and regulatory advice to the Clinical Studies Department staff.
• Develop and deliver training related to clinical studies within the department and across the company as required.
• You will be the main interface with the corporate Quality Management Department allowing synchronization and streamlining of processes and systems.
• Planning and performing internal audits, generating respective audit reports, and diligently initiate, follow up and document CAPAs accordingly.

Key Skills:

• Outstanding organisation skills combined with an analytical mindset and strong decision-making skills.
• A motivated team player with a high level of integrity and, the ability to prioritize and to work autonomously on multiple projects.
• Excellent communication and presentation skills (English and German) with the ability to build quick rapport with all levels of internal and external customers.

Requirements:

• The ideal candidate will require a scientific degree (or equivalent educational background) with a minimum of 5 years' experience in the field of quality assurance or management in clinical research, preferably in biotech or pharma companies.
• Experience in establishing and writing SOPs, processes, user manuals and/or work instructions.
• Experience in developing and delivering technical training to operational staff of advantage.
• Strong knowledge of clinical studies (ideally non-interventional) and related national and international regulatory requirements and guidelines including but not limited to ICH-GCP, FDA CFR 21 and EMA Guidelines, AMG.
• Proficiency in standard MS Office applications; skills in using Microsoft Visio to develop process flowcharts would be beneficial.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.