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GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Auditing GCP/GCLP compliance for cancer immunotherapy development. 5+ years life sciences audit experience required. Job bike, job ticket, and relocation allowance.
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
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
Work Experience
- 5 years
Education
- Bachelor's degree
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
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GCP/ GCLP Auditor as Senior Manager Clinical Quality Assurance(m/w/x)
Auditing GCP/GCLP compliance for cancer immunotherapy development. 5+ years life sciences audit experience required. Job bike, job ticket, and relocation allowance.
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
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
Work Experience
- 5 years
Education
- Bachelor's degree
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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Immatics Biotechnologies GmbH
Industry
Healthcare
Description
The company combines the discovery of true targets for cancer immunotherapies with the development of T cell receptors to enable robust T cell responses against cancer.
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