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IT Compliance Manager, IT Security Officer
BA.UnternehmensgruppeIT Compliance Manager securing pharmaceutical IT systems and GxP compliance. Managing ISMS, validation, audits, and regulated IT service qualifications.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in information security management, compliance with pharmaceutical regulations, and the development of IT security policies. Proficient in conducting audits, risk assessments, and maintaining validation documentation in a regulated environment.
Highest-signal resume keywords
Information Security ManagementGxP/GMP ComplianceISO 27001 KnowledgeRegulatory Frameworks HandlingIT Infrastructure Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
IT SecurityGxP CompliancePharmaceutical RegulationsValidation DocumentationRisk AssessmentSecurity Awareness TrainingInfrastructure QualificationSOP DevelopmentIT ComplianceAudit Planning
Soft Skills
CommunicationStakeholder ManagementCollaboration
Tools & Technologies
ISMS DevelopmentPhishing SimulationsIT Service Provider QualificationRegulatory Inspection Support
Certifications & Qualifications
ISO 27001 CertificationVdS 10100 Certification
Industry Keywords
EU GMPAMGAMWHVApoGGAMP 5
Tech Stack
Tools & technologiesCloud
About the role
Key responsibilities & impact- Assume formal mandate responsibility for information security across the entire company
- Serve as the central point of contact for internal stakeholders as well as external partners, authorities, and auditors
- Contribute to the further development of the ISMS in accordance with VdS 10100 and, prospectively, ISO 27001
- Maintain the IT security policy
- Support security-related matters in projects, procurement activities, and audits
- Design and conduct security awareness initiatives, including training formats and phishing simulations
- Take responsibility for IT compliance with pharmaceutical requirements in a regulated environment
- Support computer system validation in accordance with GAMP 5 and EU GMP Annex 11
- Conduct infrastructure qualification (IQ/OQ/PQ)
- Support business departments in operating their IT systems in compliance with applicable requirements
- Independently maintain validation documents, qualification reports, and change control documentation
- Continuously develop the SOP lifecycle for GxP-relevant IT processes
- Qualify IT service providers and suppliers in a regulated environment
- Conduct audit planning and risk assessments and ensure GxP-compliant documentation
- Prepare for and support regulatory inspections and internal audits in collaboration with Quality Management and Regulatory Affairs
- Represent the company before external auditors
- Ensure that regulatory requirements are met from an IT perspective
Requirements
What you’ll need- Completed IT training with professional experience in IT security and GxP/GMP compliance
- Alternatively, career changers with a pharmaceutical background (QA/QM) and solid additional IT qualifications
- Alternatively, a completed degree in Computer Science, Business Informatics, IT Security, or a comparable field
- Conceptual understanding of IT infrastructure and architectures (networks, servers, cloud, directory services)
- Confident handling of regulatory frameworks and technical documentation (SOPs, validation plans, risk analyses)
- Ability to assess IT services on the basis of regulatory frameworks and technical documentation
- Knowledge of pharmaceutical regulations with an IT focus, such as EU GMP, AMG, AMWHV, or ApoG
- Knowledge of information security frameworks, such as ISO 27001, VdS 10100, and BSI IT-Grundschutz
Benefits
Comp & perks- 13th-month salary
- 30 days of annual leave
- Home office opportunities
- Free Hansefit membership
- Corporate Benefits
- Business bike leasing
- Discounted charging for electric vehicles
- Travel allowance for commutes of 25 km or more
- Health promotion programs (workshops, training, preventive medical examinations, etc.)
- On-site restaurant
- Employee events