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.
Your Contribution:
* Execute compliance activities for systems, such as plans, reports, tests, changes, periodic reviews, and deviations
* Provide necessary support to meet regulatory and information security requirements for regulated systems projects
* Serve as the primary contact for CSV-related matters for GxP-computerized systems and act as a liaison between technology-based solutions and the IT Compliance on IT GRC unit
* Review and approve project-related documents for GxP relevant systems, including determining GxP-applicability for all GxP- and non-GxP relevant systems
* Establish a trusted partnership with the assigned IT technology-based function, understanding business drivers, and provide required day-to-day operational support
* Review and approve GxP-impacted deviations, ensuring appropriate CAPA implementation
* Contribute to the preparation of compliance strategies and execute plans for systems associated with respective functions
* Review and approve periodic review reports for GxP computerized systems and manage any gaps within the CAPA management system
* Provide audit support as assigned and offer necessary compliance support for any resulting CAPAs
A Good Match:
* University degree in Information Technology, Life Sciences, Pharmacy, Engineering or equivalent level
* 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 understanding of global regulations and health authorities’ expectations governing computerized systems (CSV, Part 11, etc.)
* 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
* Good understanding in system application management, its quality support approach and industry best practices (ITIL, ITSM, etc.)
* 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.)
* 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
Your Benefits:
It's our priority to support you:
* 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
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 1 PM to 3 PM CET).
Job ID 11372 (please always specify if you have any questions)
By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.