1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Full-timeOn-siteSenior
Basel
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121201 F. Hoffmann-La Roche AG
Data Integrity Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 - 15 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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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121201 F. Hoffmann-La Roche AG
Data Integrity Lead(m/w/x)
Basel
Full-timeOn-siteSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 8 - 15 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
- German – Basic
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of 1201 F. Hoffmann-La Roche AG 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.
About the Company
1201 F. Hoffmann-La Roche AG
Industry
Healthcare
Description
Roche is dedicated to advancing science and ensuring access to healthcare for everyone, with over 100,000 employees globally.
Not a perfect match?
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