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Senior Project Manager – GxP Infrastructure


Location: Cambridge, Massachusetts
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Description

Sr GxP Infrastructure Project Manager

Cambridge MA

The GxP Infrastructure Project Manager position will be responsible for managing all of the project activities for the Compliance Assessment of GxP Infrastructure and Applications.  This will include leading the effort to assess local infrastructure compliance as well as enterprise application compliance.  The position requires solid experience of project management in the GxP Infrastructure space.

The candidate will be fully accountable for successful project delivery and responsible for the overall planning, management and execution for the project. The Project Manager will develop a well-structured project plan that clearly defines the governance, scope, resource requirements, timeline, and budget for the project.

Principal Responsibilities

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

Minimum Experience Requirements

8+ years’ experience of hands on IT Project Delivery in GxP Infrastructure and working knowledge of Infrastructure systems – must be able to hold technical & functional conversations.

8+ years’ experience implementing complex, cross-functional projects solutions. 

At least 2 Infrastructure projects (3-4 years) experience

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.

 

Desired Experience

Biotech/Pharma Manufacturing Site Experience

Software Validation Remediation Projects

Minimum Education Requirements

BA or BS (ideally Computer Science, Business or Supply Chain/Manufacturing/Operations).

Formal project management qualification is preferred (PMP or similar)

Travel

Travel to Europe and North Carolina.  1x Month Possible.


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