19.03.2026 aktualisiert

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100 % verfügbar

IT Advisory / Compliance-Security Consultant with 20+ Years Experience

Freiburg, Deutschland
Nur Remote
Diplom Biologe (MSc Genetics/Microbiology)
Freiburg, Deutschland
Nur Remote
Diplom Biologe (MSc Genetics/Microbiology)

Profilanlagen

Final Testimonial 2012-2019.pdf
CV 2025 Experiences E.pdf

Skills

AuditsKundenbeziehungsmanagementProzessoptimierungComplianceInformationssicherheitBeratungKundendatenmanagementData IntegrationDatenmanagementMedizinische SoftwareITILIt Service ManagementPythonOperational ExcellenceSoftwareentwicklungSQLSystemtestsFlaskRisikoeinschätzungData LakeTeam ManagementSicherheitsbestimmungenRisikomanagementGXP
Compliance and Risk Management
Expertise in CSV & GxP Compliance, IT Service Management (ITIL), and Risk Management & Audit Readiness.
IT Security
Proficiency in IT Security Risk Assessment & Cyber Security Checks, as well as Data Integration & System Validation.
Project and Team Management
Strong capabilities in Team Leadership & Global Collaboration, Process Optimization & Continuous Improvement.
Software Development
Experience with Python, SQL, Flask for healthcare software development.
Regulatory Compliance
Knowledge of GxP, FDA standards, and ISO norms (13485, 14971:2019, 27000).
Data Management
Proficiency in managing data integration, data lakes, and customer data management solutions.
CRM Systems
Experience in managing global CRM systems and ensuring operational excellence.

Erfahrung

Berufserfahrungmehr als 10 Jahre
Freelancer seit2019

Sprachen

DeutschMutterspracheEnglischMutterspracheFranzösischGrundkenntnisse

Projekthistorie

Validation Lead

Client can not be revealed. CSV documentation based on SCRUM approach.

MediMon Project Lead

CF IT Advisory // Compliance-Security

Sonstiges

< 10 Mitarbeiter

Directed development and validation of GxP-compliant Flask/Python/MySQL application in healthcare sector. Designed scalable system architectures for data security and regulatory compliance.

CSV Expert

Client does not want to be disclosed

Pharma und Medizintechnik

500-1000 Mitarbeiter

Revalidated critical systems like SAP ECC programs for German medical device company. Redesigned risk management process to align with latest regulatory requirements.

Service Assurance Consultant

Novartis Pharma AG

Pharma und Medizintechnik

>10.000 Mitarbeiter

Established Wiki-based process description for IT Application Management group, ensuring GxP and ITIL compliance.

IT Service Operations Manager

Novartis Pharma AG
Managed global team overseeing IT service operations for commercial applications. Implemented IAM and SOC tools for enhanced security and compliance.

Head of Data Solutions

Novartis Pharma AG

Pharma und Medizintechnik

>10.000 Mitarbeiter

Directed team managing data integration, data lakes, and customer data management solutions. Maintained GxP compliance for all systems.

CRM Operations Head

Novartis Pharma AG

Pharma und Medizintechnik

>10.000 Mitarbeiter

Managed global CRM systems, ensuring operational excellence and compliance. Spearheaded platform updates using CSV-compliant testing procedures.

Head of Quality Management & Validation Europe

Novartis Pharma AG
Responsible for QM and Computer System Validation in Europe. Deployed Quality Manual 5.2 and systems validation approach. Validated HPLC systems within TRD.

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