- Job no: SNFIJP00003988
- Categories: Healthcare
ITS Project Manager
End: December 31, 2021
Location: Toronto, ON
Our client is a global leader in the growing and highly innovative vaccines industry. The client is seeking external support for two projects:
1) Electronic logbooks Pilot: implementation and validation of off the shelf software for digitizing paper forms and logbooks used with manufacturing process. This project is a pilot and requires defining deployment process for other sites, and evaluation of software to confirm expected benefits at conclusion of pilot.
2) NuGenesis SDMS 8 Rollout: migration of laboratory instruments from legacy NuGenesis 7 to the client global instance of NuGenesis 8 for archival of instrument data.
The ITS Project Manager position is ultimately responsible for all aspects of the project. This position will lead and coordinate the project team including members from ITS, Manufacturing, QC and Site Quality & Validation teams in design, build, validation, and deployment.
- Prepare Project Plans. Execute projects according to approved Project Plans. Coordinate and track business and ITS activities required to deliver project.
- Maintain project schedules following ITS Project Management Methodology (PUMA) to ensure projects are delivered on time and on budget per defined scope. Manage issues impacting project schedule as they arise and proactively propose solutions. Identify, track and manage project risks.
- Monitor and control the project progress and provide visibility on status. Organize, prepare and report to the Project Steering Committee.
- Facilitate project meetings, including providing agendas, meeting minutes, and ensuring that meetings are effective. Utilize Microsoft Teams for project team collaboration.
- Coordinate with external vendors, ITS quality, global quality, site quality, and internal ITS infrastructure teams as needed to meet the project deliverables.
- Work closely with business project leads and ITS team to document requirements, define business processes, and determine configuration settings. Participate in development of electronic logbooks as needed.
- Coordinate with Validation Expert (VEX), User Project Lead (UPL), and ITS Project Lead (IPL) to produce, review, and obtain approval for technical and validation documentation such as User Requirements Specifications, Functional Specification, Design Specifications, Protocols, Test Scripts, and Installation Procedures as required by the project. Ability to assist in documentation creation as required.
- Support knowledge transfer on electronic logbook development to internal staff.
- Ensure support model is identified for delivered solutions and coordinate transition to support organizations as required.
- Understand the client computer validation process & the client PUMA methodology for executing projects.
- 5+ years experience as a Project Manager in software / IT systems deployment
- BA/BS Sciences, Engineering, Information Systems, or Business Studies
- Strong technical documentation, communication, and reporting skills
- Strong skills with database structures
- Software administration experience
- SDLC experience
- Thorough knowledge of all desktop personal productivity software (i.e. Office, Project, Visio)
- Computer Systems Validation experience
- Prior experience in GxP FDA-regulated environment
- Ability to manage relationships with external vendors.
- Published on 09 Apr 2021, 2:40 PM