Aenova Holding GmbH
Head of Corporate IT-Security and Compliance(m/w/x)
Full-timeOn-siteSenior
Starnberg
New Job?Nejo!
Your personal AI career agent
IMImmunic AG
IT Compliance & Computer System Validation Manager(m/w/x)
Gräfelfing
Full-timeOn-siteSenior
Nejo AI Summary
Validating GxP IT systems and managing QMS documentation for biotech/pharma. 5-7+ years CSV experience with GAMP 5, 21 CFR Part 11, and cloud validation required. Stock options, Wellpass, and OpenUp benefits.
Requirements
- Degree in Computer Science, Life Science, Engineering, Quality, or related field
- 5-7+ years IT Compliance / Computer System Validation experience in Biotech or Pharma
- Skilled in GAMP 5, 21 CRF Part 11, EU Annex 11, Data Integrity, and cloud/SaaS validation experience
- Proven experience with GxP computerized systems and supporting regulatory inspections
- Knowledge of SDLC, agile delivery models, cybersecurity, data privacy, and macOS
- Pragmatic, risk-based mindset with strong eye for detail and high documentation standards
- Excellent communication and collaboration skills for driving change in fast-paced digital environment
- Business-fluent English
Tasks
- Ensure GxP-compliant operation of IT systems
- Validate IT systems throughout their lifecycle
- Maintain IT QMS documentation
- Manage IT-related risk assessments
- Handle IT-related CAPAs and deviations
- Manage IT-related change controls
- Lead CSV activities from classification to decommissioning
- Validate clinical, laboratory, manufacturing, ERP, document management, and cloud/SaaS systems
- Conduct vendor assessments and supplier qualifications
- Bridge IT, Quality, and business interests
- Provide guidance during implementations and upgrades
- Support audits
- Review and approve validation deliverables
- Train system owners and users on compliance
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GAMP 5
- 21 CRF Part 11
- EU Annex 11
- Data Integrity
- cloud validation
- SaaS validation
- GxP computerized systems
- SDLC
- agile delivery models
- cybersecurity
- data privacy
- macOS
Benefits
Competitive Pay
- Stock option program
Healthcare & Fitness
- Wellpass
Mental Health Support
- OpenUp
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immunic 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.
Not a perfect match?
- Helsing
Compliance Verification Engineer(m/w/x)
Full-timeOn-siteSeniorMünchen - Bavarian Nordic GmbH
Validation & Compliance Professional(m/w/x)
Full-timeOn-siteExperiencedMartinsried - Entrix
(Senior) IT Manager - Operations & Security(m/w/x)
Full-timeOn-siteSeniorMünchenfrom 85,000 - 95,000 / year
IMImmunic AG
IT Compliance & Computer System Validation Manager(m/w/x)
Gräfelfing
Full-timeOn-siteSenior
Nejo AI Summary
Validating GxP IT systems and managing QMS documentation for biotech/pharma. 5-7+ years CSV experience with GAMP 5, 21 CFR Part 11, and cloud validation required. Stock options, Wellpass, and OpenUp benefits.
Requirements
- Degree in Computer Science, Life Science, Engineering, Quality, or related field
- 5-7+ years IT Compliance / Computer System Validation experience in Biotech or Pharma
- Skilled in GAMP 5, 21 CRF Part 11, EU Annex 11, Data Integrity, and cloud/SaaS validation experience
- Proven experience with GxP computerized systems and supporting regulatory inspections
- Knowledge of SDLC, agile delivery models, cybersecurity, data privacy, and macOS
- Pragmatic, risk-based mindset with strong eye for detail and high documentation standards
- Excellent communication and collaboration skills for driving change in fast-paced digital environment
- Business-fluent English
Tasks
- Ensure GxP-compliant operation of IT systems
- Validate IT systems throughout their lifecycle
- Maintain IT QMS documentation
- Manage IT-related risk assessments
- Handle IT-related CAPAs and deviations
- Manage IT-related change controls
- Lead CSV activities from classification to decommissioning
- Validate clinical, laboratory, manufacturing, ERP, document management, and cloud/SaaS systems
- Conduct vendor assessments and supplier qualifications
- Bridge IT, Quality, and business interests
- Provide guidance during implementations and upgrades
- Support audits
- Review and approve validation deliverables
- Train system owners and users on compliance
Work Experience
- 5 - 7 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- GAMP 5
- 21 CRF Part 11
- EU Annex 11
- Data Integrity
- cloud validation
- SaaS validation
- GxP computerized systems
- SDLC
- agile delivery models
- cybersecurity
- data privacy
- macOS
Benefits
Competitive Pay
- Stock option program
Healthcare & Fitness
- Wellpass
Mental Health Support
- OpenUp
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Immunic 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
Immunic AG
Industry
IT
Description
Immunic Therapeutics is a biotechnology company developing immunology therapies for chronic inflammatory and autoimmune diseases.
Not a perfect match?
- Aenova Holding GmbH
Head of Corporate IT-Security and Compliance(m/w/x)
Full-timeOn-siteSeniorStarnberg - Helsing
Compliance Verification Engineer(m/w/x)
Full-timeOn-siteSeniorMünchen - Bavarian Nordic GmbH
Validation & Compliance Professional(m/w/x)
Full-timeOn-siteExperiencedMartinsried - Entrix
(Senior) IT Manager - Operations & Security(m/w/x)
Full-timeOn-siteSeniorMünchenfrom 85,000 - 95,000 / year