CQV Lead - Greenfield Build jobs in United States
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Darwin Recruitment · 1 day ago

CQV Lead - Greenfield Build

Darwin Recruitment is seeking a CQV Lead for a Greenfield Pharmaceutical Biologics Facility. The role involves providing technical leadership and ensuring operational readiness for commercial manufacturing, while managing project controls and stakeholder communications.

Staffing & Recruiting
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Growth Opportunities
Hiring Manager
Wesley Cann
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Responsibilities

Overseeing the journey from URS/FDS through IQ/OQ/PQ to final Summary Reports
Proactively identifying scope creep and communicating schedule/cost impacts
Utilizing Earned Value Management (EVM) to track team productivity and milestone completion
Managing the technical critical path to ensure on-time delivery
Serving as the technical point of contact for life science clients
Ready for domestic and international travel to support site-specific execution
Fluent in English with high-caliber technical writing skills

Qualification

CQVCSVGxPEarned Value ManagementOperational ReadinessStakeholder ManagementTechnical Writing

Required

10+ Years Experience: Proven track record in CQV, CSV, and GxP environments
Full Lifecycle Mastery: Overseeing the journey from URS/FDS through IQ/OQ/PQ to final Summary Reports
Operational Readiness: Ensuring the facility is technically and regulatorily prepared for commercial manufacturing
Budget & Scope: Proactively identifying scope creep and communicating schedule/cost impacts
Performance Metrics: Utilizing Earned Value Management (EVM) to track team productivity and milestone completion
Schedule Ownership: Managing the technical critical path to ensure on-time delivery
Stakeholder Management: Serving as the technical point of contact for life science clients
Mobility: Ready for domestic and international travel to support site-specific execution
Compliance: Fluent in English with high-caliber technical writing skills

Preferred

Experience having worked on a Greenfield site previously is highly beneficial

Company

Darwin Recruitment

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Founded in 2001, Darwin Recruitment is a leading global STEM recruitment business with a specialist focus in Technology, Renewable Energy, Life Sciences, Space & Satellite, and Engineering.

Funding

Current Stage
Growth Stage
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