Director Clinical Quality Assurance (m/f)

Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts.

We are looking for a

Director Clinical Quality Assurance (m/f)

for a permanent position in Baden-Württemberg

Reference number: 97300/1


Your Duties:

• Support strategies in order to assess compliance with applicable internal/external standards across the company.
• Support the definition and implementation of a comprehensive and consistent auditing approach applicable to clinical study activities and GCP-related systems, facilities and tools in liaison with partners.
• Develop study-specific audit plans in concert with development partners.
• Coordinate audits of clinical research activities.
• Support the coordinated development, review and implementation of clinical quality documents (policies, standard operating procedures, working practices, etc).
• Support the preparation of inspections related to GCP activities, processes or facilities and interact with regulatory authorities during these inspections.
• Provide information for the ongoing education and training of clinical investigators and development personnel relative to GCP standards, regulatory requirements, and internal company SOPs.

Your Qualifications:

• Advanced academic degree in Life Sciences or Medicine.
• Profound experience in clinical research.
• In depth knowledge of regulatory requirements applicable to clinical development.
• Knowledge/experience in quality approach, system and auditing processes.
• Communication, organization and presentation skills.
• Superior negotiation and influencing skills.

• Fluent command of spoken and written English and German.
   

Interessiert?

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