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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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Firmenfahrrad
- Job bike
Öffi Tickets
- Job ticket
Gesundheits- & Fitnessangebote
- Health programs
Kinderbetreuung
- Childcare benefits
Sonstige Zulagen
- Relocation allowance
Team Events & Ausflüge
- Company summer and winter events
Noch nicht perfekt?
- Immatics Biotechnologies GmbHVollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München, Berlin
- Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
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QMS Expert Process Validation(m/w/x)
Vollzeitmit HomeofficeSeniorBöblingen - ewimed
Teamlead QA / Quality Assurance Medizintechnik(m/w/x)
Vollzeitmit 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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Benefits
Firmenfahrrad
- Job bike
Öffi Tickets
- Job ticket
Gesundheits- & Fitnessangebote
- Health programs
Kinderbetreuung
- Childcare benefits
Sonstige Zulagen
- Relocation allowance
Team Events & Ausflüge
- Company summer and winter events
Über das Unternehmen
Immatics Biotechnologies GmbH
Branche
Healthcare
Beschreibung
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.
Noch nicht perfekt?
- Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München, Berlin - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München - Immatics Biotechnologies GmbH
Director Clinical Sciences(m/w/x)
Vollzeit/Teilzeitmit HomeofficeManagementTübingen, München - Philips
QMS Expert Process Validation(m/w/x)
Vollzeitmit HomeofficeSeniorBöblingen - ewimed
Teamlead QA / Quality Assurance Medizintechnik(m/w/x)
Vollzeitmit HomeofficeSeniorHechingen