The AI Job Search Engine
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
Not a perfect match?
- Immatics Biotechnologies GmbHFull-time/Part-timeWith HomeofficeExperiencedTübingen, München
- Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München, Berlin - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Full-time/Part-timeWith HomeofficeManagementTübingen, München - Philips
QMS Expert Process Validation(m/w/x)
Full-timeWith HomeofficeSeniorBöblingen - ewimed
Teamlead QA / Quality Assurance Medizintechnik(m/w/x)
Full-timeWith HomeofficeSeniorHechingen
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
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.
Not a perfect match?
- Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedTübingen, München, Berlin - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Full-time/Part-timeWith HomeofficeManagementTübingen, München - Philips
QMS Expert Process Validation(m/w/x)
Full-timeWith HomeofficeSeniorBöblingen - ewimed
Teamlead QA / Quality Assurance Medizintechnik(m/w/x)
Full-timeWith HomeofficeSeniorHechingen