Engineer IT Compliance

Beschreibung

Job Zusammenfassung In dieser Rolle führst du Compliance-Aktivitäten für IT-Systeme durch, managst CSV-Beziehungen, entwickelst Strategien und unterstützt interne sowie externe Audits in regulierten Umgebungen. Job Zusammenfassung In dieser Rolle führst du Compliance-Aktivitäten für IT-Systeme durch, managst CSV-Beziehungen, entwickelst Strategien und unterstützt interne sowie externe Audits in regulierten Umgebungen. Deine Rolle im Team As a Engineer IT Compliance, you are responsible for leading and executing compliance activities for IT systems, ensuring alignment with regulatory and information security requirements. Your scope includes managing plans, reports, testing, changes, periodic reviews, and deviations. You act as the primary point of contact for CSV-related topics, serving as the link between technology teams and the IT Compliance function within the IT GRC unit. In this capacity, you build strong partnerships with IT functions, provide day-to-day operational support, and review and approve project documentation as well as GxP relevant deviations. You also contribute to the definition of compliance strategies, implement system-level compliance plans, manage gaps within the CAPA Management System, and support internal and external audits as needed. Overall, the role is pivotal in safeguarding the compliance and integrity of GxP-computerized systems across the organization. Unsere Erwartungen an dich Ausbildung University degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent level. Qualifikationen Solid understanding of global regulations and health authorities' expectations governing computerized systems (CSV, Part 11, etc.). Good understanding in system application management, its quality support approach and industry best practices (ITIL, ITSM, etc.). Strong analytical and problem-solving mindset and the ability to think critically and strategically. Proficient conflict management skills to mediate and resolve disagreements between stakeholders. Excellent written and verbal communication skills for clear communication, content delivery, and stakeholder interaction. Erfahrung A minimum of 3 years of overall IT experience and a minimum of 5 years of relevant experience in the pharmaceutical industry and in particular within regulated functions such as IT quality and compliance. Solid experience in the development, implementation and lifecycle management of computerized systems in regulated environments. Experience in quality management of premises and cloud-based regulated environments. Highly experienced in the operational management of GxP-solutions, including its related technologies to support the operation. Experience in the development, implementation and lifecycle management of key computerized systems in pharmaceutical development, manufacturing, quality, commercial and infrastructure space (e.g. ERP/SAP, MES, LIMS, CRM, IAM, etc.). Unser Angebot Your flexibility: flexible hours | vacation account. Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning. Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential. Your health and lifestyle: Company bike. Your mobility: Job ticket | Deutschlandticket. Your life phases: Employer-funded pension | Childcare. Benefits Work-Life-Integration ⏰ Flexible Arbeitszeiten 🏠 Home Office 🍼 Kinderbetreuung Mehr Netto 🚎 Verkehrsmittel-Zuschuss 👴🏻 Betr. Altersvorsorge Themen mit denen du dich im Job beschäftigst Cyber/Security Metadaten Level: Erfahren Job Feld: IT, Security, Test/QA Anstellung: Vollzeit Vertragsart: Unbefristetes Dienstverhältnis Arbeitsmodell: Onsite Unternehmenstyp: Etablierte Firma Branche: Pharma, Chemie, Biotech Ort: Mainz | Deutschland

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