GxP Project Manager (Pharma)

Hybrid in San Francisco, CA, US • Posted 5 hours ago • Updated 5 hours ago
Contract Corp To Corp
Contract W2
Contract Independent
6 Months
50% Travel Required
Hybrid
$80 - $90/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Pharmaceutical or Biotechnology industry
  • GxP-regulated projects
  • GMP
  • GxP
  • GAMP 5
  • FDA regulations
  • 21 CFR Part 11
  • MES
  • LIMS
  • QMS
  • ERP
  • Electronic Batch Records (EBR)
  • Manufacturing Systems

Summary

Job Title: GxP Project Manager

Location: Bay Area, CA

Duration: 6+ months with possible of extension

Required Qualifications

  • Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.
  • 8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.
  • 5+ years managing GxP-regulated projects.
  • Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.
  • Experience managing Computer System Validation (CSV) projects.
  • Experience delivering projects involving MES, LIMS, QMS, ERP, Electronic Batch Records (EBR), or Manufacturing Systems.
  • Strong knowledge of SDLC, Agile, Waterfall, or Hybrid project methodologies.
  • Excellent stakeholder management and communication skills.
  • Experience working with global cross-functional teams and third-party vendors.

Preferred Qualifications

  • PMP or PRINCE2 Certification.
  • Experience with Veeva Vault, Werum PAS-X, Rockwell Pharma Suite, Siemens Opcenter, SAP S/4HANA, TrackWise, Lab Vantage, or Master Control.
  • Experience in commercial manufacturing or clinical supply environments.
  • Familiarity with cloud-based GxP systems and digital transformation initiatives.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: nexinfo
  • Position Id: 9060959
  • Posted 5 hours ago
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