What are the responsibilities and job description for the IT Project Managerwith GxP concepts Experience @ Sunnyvale, California _ Only on W2 position at BURGEON IT SERVICES LLC?
Role: IT Project Manager
Location: Hybrid (mandatory 3 days work from client s office in Sunnyvale, California)
Duration: Long Term
Only on W2
Please share the resume at
Domain (Industry): Life Sciences & Pharma
Mandatory skills*
IT Project Management, Awareness of GxP concepts
Desired skills*
PMP, SAFe, or similar project management certifications
JD
Role Summary
Client is seeking an experienced IT Project Manager to lead and deliver Product Lifecycle Management (PLM) initiatives in a regulated (GxP) environment. The Project Manager will be responsible for end-to-end delivery of PLM projects, coordinating cross-functional teams, managing timelines and risks, and ensuring compliance with applicable quality and regulatory requirements.
This role requires strong hands-on project management skills, experience delivering enterprise PLM solutions, and working knowledge of GxP compliance within life sciences or medical devices.
Key Responsibilities
PLM Project Delivery
- Lead end-to-end delivery of PLM projects, including planning, execution, monitoring, and closure
- Manage project scope, schedule, budget, risks, and dependencies across multiple workstreams
- Drive alignment between business stakeholders, IT teams, vendors, and system integrators
- Ensure projects are delivered on time, within scope, and to expected quality standards
Stakeholder & Governance Management
- Act as the primary point of contact for project stakeholders and leadership
- Facilitate project governance forums, status reviews, and executive updates
- Proactively manage risks, issues, and change requests using established governance processes
GxP & Compliance Oversight
- Ensure PLM implementations comply with GxP regulations (e.g., FDA, ISO, CSV principles as applicable)
- Coordinate with Quality, Validation, and Compliance teams to support validation activities
- Ensure required documentation (project plans, requirements, test evidence, approvals) is produced and maintained
Delivery & Operational Excellence
- Apply standard project management methodologies (Agile, Waterfall, Hybrid as applicable)
- Oversee vendor and partner deliverables to ensure quality and compliance expectations are met
- Promote best practices for project controls, documentation, and communication
Salary : $50 - $55