PM Group ยท 9 hours ago
Project Manager - Operational Readiness
Somerset, NJ
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expPM Group is seeking an Operations Readiness Project Manager to support biopharmaceutical and pharmaceutical manufacturing clients through late-stage project execution, startup, and operational handover. This role involves leading cross-functional readiness activities and ensuring systems, equipment, and processes are prepared for compliant operations.
Architecture
Responsibilities
Lead operations readiness planning and execution across commissioning, qualification, validation, manufacturing, and quality functions
Manage external contractors, equipment vendors, and internal stakeholders to ensure readiness activities are completed on schedule, within scope, and aligned to budget
Own and maintain integrated project schedules, including CQV milestones, interdependencies, and resource constraints
Identify, track, and mitigate project and operational readiness risks, supporting contingency and recovery planning as required
Coordinate and oversee commissioning, qualification, and validation readiness, ensuring systems and equipment meet regulatory and operational requirements
Manage scope changes and readiness impacts to ensure original project and startup objectives are maintained
Develop cost estimates and forecasts related to readiness activities, including labor, vendor support, and supporting services
Prepare and deliver project status reports, dashboards, and executive presentations
Act as a primary interface between Engineering, CQV, Manufacturing, Quality, and Facilities teams to support a smooth handover to operations
Facilitate readiness reviews, risk workshops, and cross-functional meetings in a cGMP environment
Support PM Group OTS governance, reporting standards, and client engagement expectations
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline (or equivalent experience)
10+ years of project management experience in biopharmaceutical or pharmaceutical manufacturing environments
Proven experience supporting operations readiness, startup, or late-stage project delivery
Strong understanding of commissioning, qualification, and validation lifecycles and their integration with manufacturing readiness
Solid knowledge of cGMP requirements, engineering lifecycles, and pharmaceutical quality systems
Familiarity with ISPE Good Practice Guides and structured project management methodologies
Demonstrated ability to manage complex, cross-functional teams and vendor partners
Excellent communication, stakeholder management, and decision-making skills
Experience facilitating meetings and driving alignment in regulated environments
Company
PM Group
PM Group is an international project delivery firm providing professional services in architecture, engineering and construction.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Sam B.
CEO
Recent News
Irish Examiner
2025-09-13
2025-09-12
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