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 processes
• Work 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 needed
• Business 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 live
• Ensure systems are meeting regulatory requirements – include GDPR, 21CFR Part 11 etc
• Ensure cybersecurity controls and concerns are factored into any IT projects
• Communicate QMS software solution status and issues to senior management.
• Ensure budget management and on budget delivery of projects
• Ensure business continuity of systems for highly regulated environment
• Delegate for Head of QMRS on technical documents/approvals
• Oversight of project team including developers to ensure business needs are met and suit the global roadmap are architecture of projects
• Ensure no major non conformities identified in audits in relation to the validation and release of GxP relevant systems
• Escalate any significant issues with the system to the vendor within 24hours with target resolution in 3 days
• Delivery of introduction or change projects for the system on time and on budget
• Responsible 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 needed
• Willingness 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 preferred
• Experience 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 SQL
• Gained 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 processes
• Proven track record in leading complex projects and solving system problems within a cross functional team
• Responsible 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 requirements
• Proven track record supporting the management of IT-projects and documentation of requirements based on best practices.
• 21CFR Part 11 e-signature knowledge
• Infrastructure, Server and Interface expertise
• GAMP 5 software validation knowledge
• Microsoft Windows server systems Management
• Relevant 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 English
• German language a benefit

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