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Program Manager GxP


Location: Cambridge, Massachusetts
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IT Program Manager – GxP

IT Portfolio Manager with a dotted line to the Infrastructure IT Functional Lead.
The GxP Program Manager position will be responsible for managing all of the program activities (from Program Initiation through Close) for the Compliance Assessment & Remediation Program encompassing all GxP Infrastructure and Site/Enterprise Applications. This will include leading the overarching program that will assess and remediate shop floor infrastructure as well as enterprise applications. The position requires solid experience of program management in the GxP space. The ideal candidate will have experience with large IT GxP Programs.
The candidate will be fully accountable for successful project delivery and responsible for the overall planning, management and execution for the project. This project primarily serves all functions within the PO&T organizations. The Project Manager will develop a well-structured project plan that clearly defines the governance, scope, resource requirements, timeline, and budget for the project.
Develop the overall project schedule and project management plan.
Monitor, challenge and ensure predictable delivery of projects – driving accountability of work stream owners and enabling escalation of risks and issues that require assistance or attention.
Monitor resources, either internal from associated IT Department or external are committed to meet project needs.
Ensure projects are delivered according to committed scope, approved budget and targeted dates.
Ensure high level of quality in solutions is delivered. Lead various program governance meetings including routine core team / program office meetings as well as escalation, steering and sponsor reviews.
Facilitate critical project reviews.
Ensure all aspects of the program’s success are contemplated and addressed.
Enable and enhance communications between matrixed IT and business teams
8+ years’ experience working as an IT professional – ideally managing projects, programs and/or portfolios
5+ years’ experience implementing complex, cross-functional project/program solutions in the GxP space with working knowledge of CAPAs / Audit Remediations
At least 2 projects/programs working with and managing a large Systems Integration partner preferred.
Demonstrable fluency in Project Management tools and techniques and of implementing projects within established software development life cycle methodologies.
Demonstrable experience of transitioning new and upgraded systems into support operations – at least 2 large, multi-discipline projects.
Biotech/Pharma Manufacturing Site Experience
Software Validation Remediation Projects
Quality Management Systems Programs
BA or BS (ideally Computer Science, Business or Supply Chain/Manufacturing/Operations).
Formal project management qualification is preferred (PMP or PGMP or similar)
Travel to Europe (Denmark) and North Carolina. 1x Month Possible.

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