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Immatics Biotechnologies GmbH
23d ago

GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)

Tübingen, München
Full-time, Part-timeWith Home OfficeSenior

Description

As a GCP/GCLP Auditor in the Senior Manager role, you will be at the forefront of ensuring clinical quality by conducting audits, creating essential documentation, and providing training. Your expertise will help maintain inspection readiness and support clinical functions in managing quality deviations.

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Requirements

  • •University degree in natural sciences or related field
  • •5+ years of experience in life sciences companies
  • •Experience in general audit execution and investigator site auditing
  • •Background in quality management within clinical trial environment
  • •Strong knowledge of GCP regulatory requirements
  • •Operational clinical trial management experience
  • •Comfortable working in a global and matrixed business environment
  • •Excellent interdisciplinary and intercultural communication skills in English and preferably German
  • •High degree of initiative, analytical reasoning, and strong problem solving skills
  • •Structured, reliable, and foresighted task approach
  • •Elevated level of individual responsibility, enthusiasm, and strong social skills

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • •Conduct internal and external audits
  • •Create and review quality-related documents
  • •Support implementation of inspection readiness concepts
  • •Prepare for and host regulatory inspections
  • •Organize and conduct quality-related training
  • •Provide quality guidance for protocol and process deviations
  • •Assist with change controls and root cause analyses
  • •Define CAPA for deviations and inspection observations
  • •Support maintenance of the clinical (e)QMS
  • •Define and interpret quality metrics and trending reports

Languages

English – Business Fluent

German – Basic

Benefits

Company Bike

  • •Job bike

Public Transport Subsidies

  • •Job ticket

Healthcare & Fitness

  • •Health programs

Childcare

  • •Childcare benefits

Additional Allowances

  • •Relocation allowance

Team Events

  • •Company summer and winter events
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immatics Biotechnologies GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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