Director, Clinical Quality

Hobson Prior - Berlin - 07-06-2022 zur Vakanz  

€120000 - €130000 per annum
Permanent
Berlin
Quality Assurance, Quality Systems

Posted:
06/06/2022
BBBH19068
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This vacancy has now expired. Please see similar roles below...

Hobson Prior are seeking a Director, Clinical Quality to join a fantastic organisation on a permanent basis with the ability to work remotely from home anywhere in Europe. For more information, please get in touch now!

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

Key Responsibilities:

  • To certify consistent professional development and inspiration, you will guide and handle the QA team.
  • You will set and handle the QA budget annually.
  • For this role, you will offer QA knowledge and direction to the research, development and supply chain teams.
  • Guarantee that an efficient change control system is positioned.
  • Perform internal reviews od QMS and reports such as protocols, ICFSs, CSRs, etc.
  • You will uphold a quality system that warrants GMP, GLP and GCP (GXP) compliance.
  • Set the QA approach rendering to the company's goals.
  • The ideal candidate will guarantee that the QA division is always suitably resourced.
  • Any other assigned duties.

Key Skills:

  • Communication skills, with the ability to be comfortable to challenge the status quo.
  • Able to plan and be organised with a high attention to detail.
  • Capable of operating within an energetic establishment that is developing and swiftly altering.

Requirements:

  • Educated to a degree level.
  • At least 10 years of experience operating in quality assurance, ideally in GCP compliance.
  • At least 5 years of experience handling quality assurance within a pharmaceutical drug development organisation.
  • Familiarity with competent authority inspection such as MHRA, FDA, etc.
  • Acquaintance with performing GCP gap examinations, GCP process reviews on an internal basis, investigator sites on an external basis and supplier reviews.
  • Comprehension of GMP needs as they link to both clinical trials and commercial product supply.
  • Willing to travel for business needs to other countries/continents.
  • GLP know-how would be beneficial but is not essential for the role.
  • Advantageous to know Veeva Vault or any other electronic QA systems, but not necessary.

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.

Hi I'm
, I manage this role

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