Systems Manager – Complaints and Pharmacovigilance

PURPOSE AND SCOPE:The System Owner will report into Quality Management and Regulatory Systems Head (QMRS) and will be responsible for overseeing the implementation and maintenance of Quality Management System (QMS) software solutions, including Pharmacovigilance (PV) and Complaints. The System Owner will also be responsible for ensuring that these software solutions are compliant with regulatory requirements and meet the needs of our Quality and Compliance teams. They will be an experienced in managing external vendors, software lifecycle management, infrastructure and interface management and experience with server/cloud management would be beneficial. PRINCIPAL DUTIES AND RESPONSIBILITIES: Expertise for guiding the business and the QMRS team on project/change requests for the PV or Complaints tools to ensure ongoing integration and improved integration of QMS processesWork with Quality and Compliance teams to understand their needs and ensure that QMS software solutions meet their requirements.Manage the QMS software development process, including planning, tracking progress, and coordinating resources.Point of contact for technical administration and maintenance and validation activities on behalf of the QMRS team and ensure interfaces operate as neededBusiness contact for technical support or escalating tickets to the software vendor.Primary contact for software vendor to share release notes information, to manage impact assessments and to coordinate subsequent validation efforts.Responsible for review of change requests from the business and the release of new capabilities in the tool.Collaborate with the IT team to define QMS software product features and benefits and develop implementation plans.Responsible for the onboarding of new sites/organizations into the tool and ensure any data migration/project tasks are completed ahead of go liveEnsure systems are meeting regulatory requirements – include GDPR, 21CFR Part 11 etcEnsure cybersecurity controls and concerns are factored into any IT projectsCommunicate QMS software solution status and issues to senior management.Ensure budget management and on budget delivery of projectsEnsure business continuity of systems for highly regulated environmentDelegate for Head of QMRS on technical documents/approvalsOversight of project team including developers to ensure business needs are met and suit the global roadmap are architecture of projectsEnsure no major non conformities identified in audits in relation to the validation and release of GxP relevant systemsEscalate any significant issues with the system to the vendor within 24hours with target resolution in 3 daysDelivery of introduction or change projects for the system on time and on budgetResponsible for the recommendations from QMRS to the business in relation to project or change requests coming into DTI.Expert and individual responsible for guiding QMRS strategy in relation to software architecture and a fully integrated Quality Management System. PHYSICAL DEMANDS AND WORKING CONDITIONS: Willingness to be on site in Bad Homburg as neededWillingness to travel within Europe and in the US as needed to support projects. EDUCATION: Bachelor's degree in Computer Science, Engineering, Quality or a related field. EXPERIENCE AND REQUIRED SKILLS: 5+ years of experience in QMS software implementation and maintenance, preferably in the medical device industry.Additionally, minimum of 2 years of general professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferredExperience managing Microsoft Windows server systems and technical architecture.Experience with software validation documentation within GxP environment and release process.Experience with QMS software solutions such as Learning Management Systems and/or Complaints systems or handling numerous QMS IT solutions at once.You demonstrate good handling of IT office tools (Email, MS Word, Excel and PowerPoint), the database tool SQLGained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)Experience and ownership of GxP system validation documentation and execution.Understanding methodologies for statistical analysis, leading transformations and managing programs and implementation of IT solutions into business processesProven track record in leading complex projects and solving system problems within a cross functional teamResponsible for the recommendations from QMRS to the business in relation to project or change requests coming into DTI.Expert and individual responsible for guiding QMRS strategy in relation to software architecture and a fully integrated Quality Management System.Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirementsProven track record supporting the management of IT-projects and documentation of requirements based on best practices.21CFR Part 11 e-signature knowledgeInfrastructure, Server and Interface expertiseGAMP 5 software validation knowledgeMicrosoft Windows server systems ManagementRelevant experience with Quality system Complaint IT Platforms (e.g. Trackwise, IQVIA, ARIS G, Oracle Argus, Veeva, Windchill etc)Knowledge and understanding of key enterprise systems used in a medical device such ERP/SAP, MES/Werum, LIMS/LabWare, CRM/Salesforce and End-to-end Processes in the medical device companies would be a benefit.high language proficiency in EnglishGerman language a benefit Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.