Our client is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with various diseases. Our client recognizes that cutting-edge science and medicines can change the course of devastating diseases.
The GxP Infrastructure Project Manager position will be responsible for managing all of the project activities (from Project Initiation through Close) 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. 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
Minimum Experience Requirements
5+ 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.
5+ 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.
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 to Europe (Denmark) and North Carolina. 1x Month Possible.
If interested, please forward your resume to firstname.lastname@example.org and call Tim Weldon at 617-315-8208.