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 Regulatory Information Management (RIMs) and Regulatory Intelligence (RI) systems. 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:

Track user access, license usage and system stabilityOwnership of vendor contracts with approvals/invoicing as neededEnsure cybersecurity controls and concerns are factored into any IT projectsSupport with data gathering for business case build for new project and budget applicationsPropose system improvement ideas whilst maintaining the broader view of the software ecosystem and interconnectivitiesTrain new administration team members when heightened access rights are needed to access servers/background of systemsSupport with system testing during validation of software toolings as needed to support the implementation team.Ensure business continuity for the systemsExpert liaison for interface management on daily basis to ensure connectivity of systems e.g. to GPDM or ERP systemsManage data migration plans from any existing technologiesLead expert for system upgrade projectsEnsure systems are meeting regulatory requirements – include GDPR, 21CFR Part 11 etcResponsible for the onboarding of new sites/organizations into the tool and ensure any data migration/project tasks are completed ahead of go liveCollaborate with the IT team to define QMS software product features and benefits and develop implementation plans.Responsible for review of change requests from the business and the release of new capabilities in the tool.Primary contact for software vendor to share release notes information, to manage impact assessments and to coordinate subsequent validation efforts.Business contact for technical support or escalating tickets to the software vendor.Point of contact for technical administration and maintenance and validation activities on behalf of the QMRS team and ensure interfaces operate as neededManage the QMS software development process, including planning, tracking progress, and coordinating resources.Work with Quality and Compliance teams to understand their needs and ensure that QMS software solutions meet their requirements.Expertise for guiding the business and the QMRS team on project/change requests for the RIMs, RI tool to ensure ongoing integration and improved integration of QMS processesCommunicate 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 projectAdditional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.

EDUCATION:

Bachelor's Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable.

 

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 architectureExperience with software validation documentation within GxP environment and release processExperience with QMS software solutions such as Regulatory Information Management (RIMs) and Regulatory Intelligence (RI) or handling numerous QMS IT solutions at once.Your work ethic is characterized by a strong self-motivated, systematic and analytical approach.Also, you pay close attention to details, have strong communication and project management skills as well as a strong service and result oriented working style.Good general Project & Program Management skills.Must be a self-starter with strong creation to execution skills.An enterprise wide mind-set.Cultural sensitivity and understanding. Able to effectively deal with international/cultural differences.Excellent oral and written communicationAbility to adapt to business strategy or changes in prioritiesStrong leadership and influencing ability through concise communication and robust interpersonal skills.Ability to work collaboratively in a cross-functional team environment.Ability to multitaskAbility to change working activity in line with priority changes and/or requests from managementKnowledge in Microsoft Windows server systems and technical architecture21CFR Part 11 e-signature knowledgeInfrastructure, Server and Interface expertiseGAMP 5 software validation knowledgeMicrosoft Windows server systems ManagementRelevant experience with Quality system IT Platforms (e.g. IQVIA, Oracle, E-norm, Veeva, Windchill etc)Knowledge of the Product Life Cycle software system, such as WindchillKnowledge 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.Willingness to be on site in Bad Homburg as neededWillingness to travel within Europe and in the US as needed to support projects.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)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.Supporting the management of IT-projects and documentation of requirements based on best practices. Bachelor's degree in Computer Science, Engineering, Quality or a related field or successfully completed a technical apprenticeship supplemented with appropriate professional experience in a comparable role•Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements

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Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

 

Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.