Digital Quality Solution Manager

Your Tasks:

- Planning and organization of the implementation of system changes & system releases
- Planning Management of IT projects to achieve an agreed result within a defined scope, time and budget.
- Hosting requirements workshops, and supporting the business with requirements documentation - along with liaising these requirements to the technical system architects.
- Managing the technical implementation in TRACKWISE and presentation of project status to leadership - along with any risks, milestones, budgetary monitoring and handling SLAs.
- Supervisor for the CSV/CSA team to ensure on time and compliant execution of the validation process for any changing or introductions to the tooling.
- System ownership responsibility for the Trackwise tool - and signatory rights for this on the necessary system documentation.
- Oversight of the periodic review and the monitoring of user usage for the system.
- Liaison for care enablement business process owners into DTI for QTRAK system
- Ensure business continuity for all systems within the responsibility of QMRS
- Ensure regulatory requirements are defined fully for any system introductions/changes
- including quality management, cybersecurity and GDPR
- Expertise for guiding the business and the QMRS team within projects, ensuring ongoing integration and improved integration of QMS processes.
- Manage DTI teams in relation to new IT project/changes to softwares on topics of global alignment, budget management, license consolidation and adhering to strategic roadmap of QMRS and DTI.
- Hosting change advisory board meetings to ensure transparency on demands coming into the QMRS department
- Capture the business cases for the projects, the options around the business cases and the pros/cons relating to the different options - on which leadership will make decisions in consideration of budget and other strategic inputs
- Provide strategic input and ensure compliance around existing tool management and any decommissioning impacts to the business
- Oversee the inputting of projects into the investment meetings/demand process
- Definition and regular review of the system with regards to maintenance costs and operational needs - ensuring the system is maintained and supported by the vendor
- Definition and regular review of recurring support tasks and obligations, through the use of the ticketing system - and the swift resolution of ticket issues for end users.
- Responsible for clarifications / escalation of unknown / new technical problems and the resolution of these with the system architects and business process owner.
- Point contact for any software audits of the Trackwise tool - providing evidences or supporting information needed to demonstrate the ongoing validated state of the tool.
- Primary contact for interfacing systems to the Trackwise tool, e.g. data warehouse or SAP - to ensure seamless integrations to other softwares within FMC.
- Provide inputs to leadership meetings for discussion around priorities and projects
- Propose system improvement ideas whilst maintaining the broader view of the software ecosystem and interacting processes
- Coordinate workshops/demonstrations with software vendors
- Support with approvals/invoicing as needed
- Maintain a broad view of the full ecosystem under the management of QMRS, monitoring and working to reduce the landscape of systems and heterogeneous processes.
- Manage a team combining of software engineers, business analysts and the business colleagues as projects are approved
- Ensure budget management and on budget delivery of projects
- Ensure business continuity of systems for highly regulated environment
- Helping set QMRS ecosystem strategy in line with Head of QMRS
- Delegate for Head of QMRS on technical documents/approvals

Your Background:

- 5 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred
- 3 years experience managing people within an IT environment
- Experience with Project Management and leading multifunctional teams
- Experience with software validation documentation within GxP environment and release process
- Experience managing budgets and on time/on budget delivery of projects
- Successfully completed studies (Bachelor/Master) in engineering or economics or comparable professional training with professional experience in a comparable function
- Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements
- Working knowledge of functionality within Trackwise system
- Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485, 21CFR820) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)
- Strong self-motivated, systematic and analytical approach
- Good analytical mind with good communication skills
- A focus