IT Compliance Specialist (m/w/d)

Midas Pharma GmbH.; Ingelheim am Rhein; Presencial; EUR 90 000 - 120 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

JobRad

EGYM Wellpass

Employee restaurant

Regular events

Resumo da oferta

Midas Pharma GmbH is seeking an IT Compliance professional to lead CSV/CSA activities, ensure GxP alignment, and maintain regulatory IT policies in a pharma/life sciences setting.

You will qualify IT infrastructure, assess cloud services, and support audits and CAPAs while advising IT and business units in data integrity and compliance.

Qualificações

• Must have degree in computer science or related field.
• Several years' experience in regulated pharma/Life sciences.
• Strong knowledge of GxP, EU-GMP Annex 11, 21 CFR Part 11, and data integrity (ALCOA+).

Responsabilidades

• Implement and monitor regulatory requirements and maintain related IT policies and SOPs.
• Own CSV/CSA activities including validation docs, risk analyses, and reviews.
• Qualify IT infrastructure and assess cloud services for compliance.
• Evaluate changes for GxP relevance and manage change and incident processes.
• Qualify IT service and cloud providers and support supplier audits.
• Prepare for audits and inspections, tracking findings and CAPAs.
• Advise IT and business, training on CSV, CSA, and data integrity.

Conhecimentos

GxP knowledge

Regulatory compliance

CSV/CSA

IT service management

Analytical thinking

Communication skills

German & English

Formação académica

Degree in computer science

Business informatics

Ferramentas

Cloud platforms

IT infrastructure

Audit tools

Descrição da oferta de emprego

Your mission

• Implement and monitor regulatory requirements (e.g., EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSA) and maintain related IT policies and SOPs
• Take ownership of Computer System Validation (CSV/CSA), including validation documentation, risk analyses, and periodic reviews
• Qualify IT infrastructure (servers, networks, cloud platforms) and assess cloud services for compliance
• Evaluate changes for GxP relevance and ensure compliant change and incident management processes
• Qualify and assess IT service providers and cloud providers, including support for supplier audits
• Prepare for and support internal and external audits and regulatory inspections (e.g., FDA, EMA), including tracking findings and CAPAs
• Advise IT and business departments and conduct training on CSV, CSA, and data integrity

Your profile

• Degree in computer science, business informatics, or a comparable qualification
• Several years of experience in a regulated pharmaceutical, biotech, or life sciences environment
• Solid knowledge of GxP requirements, EU-GMP Annex 11, 21 CFR Part 11, GAMP 5, CSV/CSA, and data integrity (ALCOA+)
• Experience with IT infrastructure, cloud technologies, and IT service management
• Analytical, risk-based thinking and a structured, independent way of working
• Strong communication skills and a high level of advisory and service orientation
• Very good German and English skills

Our Offer

• A responsible key role at the intersection of IT, quality, and compliance
• Individual training and development opportunities
• Flexible working hours and a modern working environment
• Various benefits such as JobRad, EGYM Wellpass, employee restaurant, regular events, and more
• We have flat hierarchies and small teams, enabling clear and direct communication that leads to fast decision‑making
• We’re looking for you as a person and want you to bring your authentic self to work – something we support through plenty of room for creativity and independence