Clinical QA Manager

Hobson Prior are looking for a Clinical QA Manager to join a brilliant pharmaceutical corporation on a permanent basis located either in Germany or Austria. Our client is focused on developing remedies from high-quality human proteins.

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

Key Responsibilities:

• For this role, you will conduct audits at clinical study sites and suppliers assisting in clinical studies to review compliance with GCP as well as with the guidelines.
• You will review retailer qualification from a QA standpoint to assist in general retailer qualification.
• Supply assistance to the development and consistent improvement of the quality management system and connected documentation system.
• Attend and provide assistance at regulatory inspections of clinical studies globally.
• The ideal candidate will serve as a QA representative within the division of international GCP compliance, for operational teams and assisted functions.
• Evaluate and provide direction to the development of clinical SOPs owned by R&D and medical affairs.
• Participate in resolving issues, supply assistance to operational teams and assist functions concerning quality connected problems.
• Any other assigned duties.

Requirements:

• Educated to a degree level in a life science discipline such as pharmacy, biological sciences, chemistry or a similar discipline.
• At least 5 years of experience within a clinical quality assurance role or within the operational performance of clinical trials and the implementation of GCP.
• Know-how of suitable ICH GCP regulations, industry best techniques, and regulatory needs.
• Comprehension of QA processes and implementation within the day-to-day operations.
• Educated/familiarity within QA systems and ideally auditing.
• Willing to travel up to 30% of the time for business needs.

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.