GxP Project Manager

We are seeking an experienced GxP Project Manager to lead and manage cross-functional GxP initiatives supporting pharmaceutical manufacturing, quality, laboratory, validation, and IT systems. The ideal candidate will have strong experience delivering GxP-compliant projects within regulated pharmaceutical or biotechnology environments while ensuring compliance with FDA regulations, GMP, GAMP 5, and 21 CFR Part 11.

• 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
• PMP or PRINCE2 Certification.
• Experience with Veeva Vault, Werum Client-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.
• Lead end-to-end planning, execution, monitoring, and delivery of GxP projects within pharmaceutical manufacturing and quality environments.
• Develop and manage project plans, timelines, budgets, resource allocation, and project deliverables.
• Coordinate cross-functional teams including Manufacturing, Quality Assurance, Validation, Regulatory Affairs, Engineering, Supply Chain, and IT.
• Ensure project activities comply with GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11 requirements.
• Manage Computer System Validation (CSV) activities including validation planning, risk assessments, IQ/OQ/PQ coordination, and documentation review.
• Facilitate project governance meetings, steering committee reviews, and executive status reporting.
• Identify project risks, issues, dependencies, and develop mitigation strategies.
• Coordinate implementation of manufacturing systems including MES, LIMS, QMS, ERP, and laboratory applications.
• Collaborate with vendors and system integrators during implementation, testing, deployment, and post-go-live support.
• Support Change Control, CAPA, Deviations, Risk Assessments, and Audit Readiness activities.
• Review and approve project documentation including URS, FRS, Design Specifications, Validation Plans, SOPs, Test Protocols, and Traceability Matrix.
• Monitor project progress using project management tools and provide regular status updates to senior leadership.
• Ensure successful execution of User Acceptance Testing (UAT), System Integration Testing (SIT), and production deployment activities.
• Drive continuous improvement initiatives to enhance project delivery, compliance, and operational efficiency.