- Coordinates all IT and EIS projects and ensures company resources are utilized appropriately and aligned with Business needs and priorities.
- Compiles project status reports, coordinates project schedules, manages project meetings, and identifies and resolves technical problems.
- Identifies and analyzes systems requirements and defines project scope, requirements, and deliverable.
- Coordinates project activities and ensures all project phases are completed and documented appropriately.
- This position will assist in defining and meeting project objectives and overseeing project quality control throughout the system development life cycle (SDLC), as well as coordinating the efforts of internal teams with external consultants to deliver projects to plan.
- Knowledge of System Development Life Cycle (SDLC) methodology and practical experience conducting computer system validation and change control for off-the-shelf, as well as in-house developed systems
- Experience with executing validation testing (IQ/OQ/PQ) of quality systems in a FDA regulated environment
- TrackWise Quality Management Tracking System (QTMS) validation experience a plus
- Knowledge of GAMP 5 and cGMP regulations including 21 CFR 820, and 21 CFR Part 11
- Knowledge of FDA and ISO
- Knowledge of Annex 11 (EU) and SOX a plus
- Ability to work well in teams and efficiently/effectively accomplish work individually or as a team member
- Excellent attention to details and results orientation
- Excellent attendance and ability to work overtime, if necessary
- Excellent organizational skills and ability to meet or exceed multiple defined deadlines when necessary
- Must have a high degree of proficiency in personal computing applications (MS-Office)
- Must have excellent written and verbal communication skills. Writing samples must be provided for review and evaluation.