Aenova Holding GmbH
Head of Corporate IT-Security and Compliance(m/w/x)
Vollzeitnur vor OrtSenior
Starnberg
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IMImmunic AG
IT Compliance & Computer System Validation Manager(m/w/x)
Gräfelfing
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- 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
Attraktive Vergütung
- Stock option program
Gesundheits- & Fitnessangebote
- Wellpass
Mentale Gesundheitsförderung
- OpenUp
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immunic 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.
Noch nicht perfekt?
- Helsing
Compliance Verification Engineer(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Bavarian Nordic GmbH
Validation & Compliance Professional(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMartinsried - Entrix
(Senior) IT Manager - Operations & Security(m/w/x)
Vollzeitnur vor OrtSeniorMünchenab 85.000 - 95.000 / Jahr - ImFusion GmbH
Quality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
Vollzeitnur vor OrtSeniorMünchen
IMImmunic AG
IT Compliance & Computer System Validation Manager(m/w/x)
Gräfelfing
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 - 7 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- 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
Attraktive Vergütung
- Stock option program
Gesundheits- & Fitnessangebote
- Wellpass
Mentale Gesundheitsförderung
- OpenUp
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Immunic 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
Immunic AG
Branche
IT
Beschreibung
Immunic Therapeutics is a biotechnology company developing immunology therapies for chronic inflammatory and autoimmune diseases.
Noch nicht perfekt?
- Aenova Holding GmbH
Head of Corporate IT-Security and Compliance(m/w/x)
Vollzeitnur vor OrtSeniorStarnberg - Helsing
Compliance Verification Engineer(m/w/x)
Vollzeitnur vor OrtSeniorMünchen - Bavarian Nordic GmbH
Validation & Compliance Professional(m/w/x)
Vollzeitnur vor OrtBerufserfahrenMartinsried - Entrix
(Senior) IT Manager - Operations & Security(m/w/x)
Vollzeitnur vor OrtSeniorMünchenab 85.000 - 95.000 / Jahr - ImFusion GmbH
Quality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)(m/w/x)
Vollzeitnur vor OrtSeniorMünchen