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Cqv lead

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Darwin Recruitment GmbH

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Location:
United States

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

CQV Lead for a Greenfield Pharmaceutical Biologics Facility. 12-month contract initially but will be a 3-year program.

Requirements:

  • 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
  • Project Controls: 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
  • Communication & Logistics: 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

Nice to have:

Experience having worked on a Greenfield site previously is highly beneficial

Additional Information:

Job Posted:
January 22, 2026

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