Debiopharm
Senior Manager Statistical Programming - CSV Lead(m/w/x)
Full-timeOn-siteSenior
Lausanne
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Optimizing CSV strategy for biopharmaceutical therapies, including system evaluation and procedural document implementation. Over 10 years of pharmaceutical quality management and 5 years of CSV experience required. Inclusive and respectful workplace, Equal-Pay certified.
Requirements
- Master’s degree in Science, Engineering, or Clinical discipline
- Over 10 years Quality Management experience in pharmaceutical industry
- At least 5 years CSV and qualification experience
- 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
- Experience in risk-based analysis for AI solutions
- Experience in validation for AI solutions
- Proven experience managing audits
- Proven experience conducting audits
- Strategic thinking
- Risk-based approach application
- Balancing high-level oversight and operational efficiency
- Proven track record leading teams of CSV professionals
- Proven track record developing teams of CSV professionals
- Experience in fast-paced environments
- Deliverables-driven
- Pragmatic
- Thriving in dynamic, fast-paced, matrix environment
- Fluent English
- Fluency in any other European language an asset
Tasks
- Lead and optimize CSV strategy for Debiopharm International SA
- Evaluate and design CSV strategy for current and new systems
- Implement CSV strategy 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
- Ensure high-quality delivery across portfolio initiatives
- Identify areas for process improvement
- Assist with change management
- Support audit planning and CAPA formulation
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
- other – Basic
Tools & Technologies
- GxP
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ICH GCP E6
- AI
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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Optimizing CSV strategy for biopharmaceutical therapies, including system evaluation and procedural document implementation. Over 10 years of pharmaceutical quality management and 5 years of CSV experience required. Inclusive and respectful workplace, Equal-Pay certified.
Requirements
- Master’s degree in Science, Engineering, or Clinical discipline
- Over 10 years Quality Management experience in pharmaceutical industry
- At least 5 years CSV and qualification experience
- 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
- Experience in risk-based analysis for AI solutions
- Experience in validation for AI solutions
- Proven experience managing audits
- Proven experience conducting audits
- Strategic thinking
- Risk-based approach application
- Balancing high-level oversight and operational efficiency
- Proven track record leading teams of CSV professionals
- Proven track record developing teams of CSV professionals
- Experience in fast-paced environments
- Deliverables-driven
- Pragmatic
- Thriving in dynamic, fast-paced, matrix environment
- Fluent English
- Fluency in any other European language an asset
Tasks
- Lead and optimize CSV strategy for Debiopharm International SA
- Evaluate and design CSV strategy for current and new systems
- Implement CSV strategy 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
- Ensure high-quality delivery across portfolio initiatives
- Identify areas for process improvement
- Assist with change management
- Support audit planning and CAPA formulation
Work Experience
- 10 years
Education
- Master's degree
Languages
- English – Fluent
- other – Basic
Tools & Technologies
- GxP
- 21 CFR Part 11
- EU Annex 11
- GAMP 5
- ICH GCP E6
- AI
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.
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