The opportunity
The main purpose of this role in the Global IT Quality and Compliance Department (IT Q&C), is to actively work on global IT projects on a manager level to provide guidance and support for validation and compliance of the computerized systems in the process of the System Development Lifecycle (SDLC); and to review and approve all required validation deliverables by following applicable policies, standards and procedures. IT projects will be primarily in the area of R&D supporting business functions such as Pharmacovigilance, Clinical, Medical Affairs, Patient Services and Support, and Regulatory Affairs.
How you’ll spend your day
• Provide project validation support by assisting the creation and reviewing and approving all required validation deliverables from a Quality perspective
• Provide system life-cycle maintenance support by creating, reviewing, approving, and maintaining validation deliverables from a Quality perspective
• Support complex processes and new system implementations requiring a new perspective using existing solutions
• Actively contribute to extend and preserve the Computer Systems Validation (CSV) knowledge in the IT Q&C team and in the company
• Provide informal guidance to customers and team members when required (e.g. in project management, usage of policies, interpretation of regulations)
• Contributes to and/or leads process improvement programs in IT Q&C and issue solving by creating plans and deliverables, providing input and training.
• Resolves complex problems using existing solutions or providing new ones
• Leads large and complex projects, innovative system validation approach, or new innovative implementations requiring a new perspective using existing solutions.
• Works independently; receives minimal guidance
• Acts as a resource for colleagues with less experience and may formally train junior staff
• Leads the work of project teams providing project management guidance when required.
