GxP Project Manager

Katalyst-Healthcares-; San Francisco (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced GxP Project Manager to lead cross-functional initiatives supporting pharmaceutical manufacturing, quality, validation, and IT systems.

You will drive end-to-end planning, manage budgets and timelines, and ensure compliance with GMP, GxP, GAMP 5 and 21 CFR Part 11 while coordinating with vendors and internal stakeholders.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, pharmacy, biotechnology or related field.
• 8+ years of Project Management experience within the pharmaceutical/biotechnology industry.
• 5+ years managing GxP-regulated projects.
• Strong knowledge of GMP, GxP, GAMP 5, FDA regulations and 21 CFR Part 11.
• Experience with CSV projects and regulatory validation activities.
• Experience with MES, LIMS, QMS, ERP, EBR, or manufacturing systems.
• PMP or PRINCE2 certification preferred.

Responsibilities

• Lead end-to-end planning, execution, monitoring and delivery of GxP projects.
• Develop project plans, timelines, budgets, and resources.
• Coordinate cross-functional teams across manufacturing, quality, validation, regulatory, engineering, and IT.
• Ensure activities comply with GMP, GxP, GAMP 5, FDA regs and 21 CFR Part 11.
• Manage CSV activities including validation planning, IQ/OQ/PQ coordination, and docs review.
• Facilitate governance meetings and provide executive status reports.
• Identify risks and mitigation strategies; manage vendor and system integrator involvement.
• Support change control, CAPA, deviations, risk assessments and audit readiness.
• Review URS, FRS, design specs, validation plans, SOPs, test protocols, and traceability.

Skills

Project management

GxP compliance

Stakeholder management

Communication skills

SDLC methodologies

Vendor management

Education

Bachelor's degree in engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field

Tools

Veeva Vault

Werum Client-X

Rockwell Pharma Suite

Siemens Opcenter

SAP S/4HANA

TrackWise

Lab Vantage

Master Control

Job description

Summary

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.

The Project Manager will collaborate with Quality, Manufacturing, Validation, IT, Regulatory Affairs, Engineering, and external vendors to successfully deliver projects on schedule, within budget, and in compliance with regulatory requirements.

Roles & Responsibilities

• 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.

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
• 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.