Debiopharm
Head of Biostatistics & Data Management(m/w/x)
Full-timeOn-siteSenior
Lausanne
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DEDebiopharm
Senior Manager Statistical Programming - CSV Lead(m/w/x)
Lausanne
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Driving CSV activities for digitalization initiatives at a Swiss biopharmaceutical company. 15+ years in pharma quality management, with 5+ years in CSV and GxP knowledge required. Equal-Pay certified, inclusive workplace.
Requirements
- Master’s degree in Science, Engineering, or Clinical discipline
- Over 15 years in Quality Management in pharmaceutical industry
- At least 5 years in CSV and qualification
- Strong working knowledge of GxP
- Strong working knowledge of 21 CFR Part 11
- Strong working knowledge of EU Annex 11
- Strong working knowledge of GAMP 5
- Strong working knowledge of ICH GCP E6
- Proven experience in managing and conducting audits
- Strategic thinking with risk-based approach
- Ability to balance high-level oversight with operational efficiency
- Deliverables-driven and pragmatic
- Ability to thrive in dynamic, fast-paced environment
- Fluent English
Tasks
- Drive CSV activities for digitalization initiatives
- Lead and optimize CSV strategy for Debiopharm International SA
- Evaluate and design CSV strategy for legacy and new systems
- Ensure CSV strategy is reflected in procedural documents
- Contribute to vendor selection and qualification
- Provide proactive quality oversight for GxP critical systems
- Direct CSV approach for project teams
- Supervise creation and approval of deliverables
- Manage test defects and risk mitigation activities
- Oversee computerized system portfolio
- Manage change controls and periodic reviews
- Maintain systems after business go-live
- Advise on CSV regulations and AI projects
- Mentor staff on CSV and CSLC activities
- Manage and develop CSV team
- Identify areas for process improvement
- Assist with CAPA formulation
- Support audit planning
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Native
- French – Basic
Tools & Technologies
- GxP
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ICH GCP E6
Benefits
Informal Culture
- Inclusive and respectful workplace
Competitive Pay
- Equal-Pay certified
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm 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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DEDebiopharm
Senior Manager Statistical Programming - CSV Lead(m/w/x)
Lausanne
Full-timeOn-siteSenior
AI/ML
Nejo AI Summary
Driving CSV activities for digitalization initiatives at a Swiss biopharmaceutical company. 15+ years in pharma quality management, with 5+ years in CSV and GxP knowledge required. Equal-Pay certified, inclusive workplace.
Requirements
- Master’s degree in Science, Engineering, or Clinical discipline
- Over 15 years in Quality Management in pharmaceutical industry
- At least 5 years in CSV and qualification
- Strong working knowledge of GxP
- Strong working knowledge of 21 CFR Part 11
- Strong working knowledge of EU Annex 11
- Strong working knowledge of GAMP 5
- Strong working knowledge of ICH GCP E6
- Proven experience in managing and conducting audits
- Strategic thinking with risk-based approach
- Ability to balance high-level oversight with operational efficiency
- Deliverables-driven and pragmatic
- Ability to thrive in dynamic, fast-paced environment
- Fluent English
Tasks
- Drive CSV activities for digitalization initiatives
- Lead and optimize CSV strategy for Debiopharm International SA
- Evaluate and design CSV strategy for legacy and new systems
- Ensure CSV strategy is reflected in procedural documents
- Contribute to vendor selection and qualification
- Provide proactive quality oversight for GxP critical systems
- Direct CSV approach for project teams
- Supervise creation and approval of deliverables
- Manage test defects and risk mitigation activities
- Oversee computerized system portfolio
- Manage change controls and periodic reviews
- Maintain systems after business go-live
- Advise on CSV regulations and AI projects
- Mentor staff on CSV and CSLC activities
- Manage and develop CSV team
- Identify areas for process improvement
- Assist with CAPA formulation
- Support audit planning
Work Experience
- 15 years
Education
- Master's degree
Languages
- English – Native
- French – Basic
Tools & Technologies
- GxP
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ICH GCP E6
Benefits
Informal Culture
- Inclusive and respectful workplace
Competitive Pay
- Equal-Pay certified
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Debiopharm 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Debiopharm
Industry
Pharmaceuticals
Description
Debiopharm is a privately-owned Swiss biopharmaceutical company committed to research in oncology and infectious diseases to improve patient outcomes and quality of life.
Not a perfect match?
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