Project Manager, Operational Readiness
Amgen · Holly Springs, NC
Clinical OperationsFull-timeCompany career page
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Role summary
Amgen seeks a Project Manager for Operational Readiness in Holly Springs, North Carolina to plan and coordinate facility startup, new product introduction, and operational transition activities. The role involves managing cross-functional readiness initiatives across manufacturing, quality, and supply chain functions while supporting compliance and inspection preparedness.
What they're looking for
- High school diploma/GED and 10 years project management experience, or equivalent education/experience combination
- Experience planning operational readiness, startup, or inspection activities in regulated pharmaceutical/biotech settings
- Knowledge of facility turnover, commissioning, qualification, and validation processes
- Ability to coordinate cross-functional teams and deliver complex activities without direct authority
- Strong project planning, scheduling, risk management, and issue-resolution capabilities
- Proficiency with Microsoft Project, Smartsheet, Excel, and Microsoft Teams
- PMP certification or equivalent project management credential preferred
What you'll be doing
- Plan, coordinate, and execute operational readiness activities aligned with facility startup and new product introduction timelines
- Develop and maintain readiness schedules, action trackers, risk logs, and milestone tracking across workstreams
- Define and track readiness requirements for personnel, training, procedures, systems, and operational processes
- Facilitate cross-functional workshops and planning sessions to align stakeholders and resolve execution issues
- Coordinate inspection readiness assessments, gap remediation, and support for regulatory inspections
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.