Senior Specialist, Operations (Project Management)
Core
Senior project leader and governance partner supporting Durham manufacturing site operations, inspection readiness, and portfolio management.
Role type
Senior Specialist, Operations (Project Management)
Builds
Integrated project schedules, readiness trackers, governance reports, and incident records for manufacturing compliance and delivery.
Domain
Regulated manufacturing (pharmaceuticals/biologics) and operations
Required skills
Cross-functional facilitation, Portfolio governance, Integrated scheduling, Risk identification, Technical writing, Incident investigation support, Change control management, Resource alignment, Executive communication, Data integrity
Preferred skills
PAI/Inspection readiness experience, Change Review Board leadership, Incident/CAPA authoring, Microsoft Project, cGMP knowledge, Lean Six Sigma, PMP certification
Technologies
Microsoft Project, Integrated readiness trackers, Portfolio tools
Responsibilities
Coordinate cross-functional Pre-Approval Inspection (PAI) and filing-readiness plans; Manage functional project portfolio prioritization and sequencing; Lead Change Review Board (CRB) operating rhythm and decision documentation; Author and coordinate incident and deviation records; Develop and maintain integrated project schedules and milestone reporting.
Seniority
Senior, hands-on IC
