IT Compliance Specialist (m/w/d)

Midas Pharma GmbH.; Ingelheim am Rhein; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

JobRad

EGYM Wellpass

Employee restaurant

Regular events

Job summary

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.

Qualifications

• 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+).

Responsibilities

• 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.

Skills

GxP knowledge

Regulatory compliance

CSV/CSA

IT service management

Analytical thinking

Communication skills

German & English

Education

Degree in computer science

Business informatics

Tools

Cloud platforms

IT infrastructure

Audit tools

Job description

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