1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Vollzeitnur vor OrtSenior
Basel
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121201 F. Hoffmann-La Roche AG
Data Integrity Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing remediation efforts with Quality Risk Management principles for regulatory inspections in the pharmaceutical industry. Expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11 and ICH Quality Guidelines required. Hybrid work model, global project collaboration.
Anforderungen
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Sciences, or related field
- 8 to 15 years of relevant pharmaceutical or biologics industry experience
- Subject matter expertise in Data Integrity principles, system validation, and computerized systems
- Proficiency in electronic document management and laboratory information systems
- Expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11 and ICH Quality Guidelines
- Strong project management and change management skills
- Ability to motivate and influence diverse, cross-functional teams
- Proficient communicator in English and German
- Ability to provide clear technical guidance and training to stakeholders
Aufgaben
- Serve as the technical SME for Data Integrity principles
- Provide expert judgment for complex technical issues
- Manage remediation efforts using Quality Risk Management principles
- Identify risks and establish priorities for compliance questions
- Represent the organization during regulatory inspections
- Act as the Quality Process Owner for Data Integrity
- Oversee DI Maturity Assessments and develop monitoring metrics
- Collaborate with Site DI Stewards to support digital GxP data governance
- Mitigate risks and assess GMP records and systems
- Align site initiatives with PTQ Coremap and data governance representatives
- Develop training materials for SMEs and stakeholders
- Lead training efforts to ensure data integrity assurance
Berufserfahrung
- 8 - 15 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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121201 F. Hoffmann-La Roche AG
Data Integrity Lead(m/w/x)
Basel
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Managing remediation efforts with Quality Risk Management principles for regulatory inspections in the pharmaceutical industry. Expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11 and ICH Quality Guidelines required. Hybrid work model, global project collaboration.
Anforderungen
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Sciences, or related field
- 8 to 15 years of relevant pharmaceutical or biologics industry experience
- Subject matter expertise in Data Integrity principles, system validation, and computerized systems
- Proficiency in electronic document management and laboratory information systems
- Expert knowledge of US and EU regulatory requirements, including 21 CFR Part 11 and ICH Quality Guidelines
- Strong project management and change management skills
- Ability to motivate and influence diverse, cross-functional teams
- Proficient communicator in English and German
- Ability to provide clear technical guidance and training to stakeholders
Aufgaben
- Serve as the technical SME for Data Integrity principles
- Provide expert judgment for complex technical issues
- Manage remediation efforts using Quality Risk Management principles
- Identify risks and establish priorities for compliance questions
- Represent the organization during regulatory inspections
- Act as the Quality Process Owner for Data Integrity
- Oversee DI Maturity Assessments and develop monitoring metrics
- Collaborate with Site DI Stewards to support digital GxP data governance
- Mitigate risks and assess GMP records and systems
- Align site initiatives with PTQ Coremap and data governance representatives
- Develop training materials for SMEs and stakeholders
- Lead training efforts to ensure data integrity assurance
Berufserfahrung
- 8 - 15 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – Grundkenntnisse
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens 1201 F. Hoffmann-La Roche AG erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
1201 F. Hoffmann-La Roche AG
Branche
Healthcare
Beschreibung
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Noch nicht perfekt?
- 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Vollzeitnur vor OrtSeniorBasel - F. Hoffmann-La Roche AG
Complaint Lead Investigator(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - 1201 F. Hoffmann-La Roche AG
GMP Compliance Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBasel - Roche
Head of Compliance and Quality Governance(m/w/x)
Vollzeitnur vor OrtSeniorKaiseraugst - Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSeniorBasel