GxP Project Manager (Pharma)

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.