Apply on Employer Site

Cellares · 2 days ago

Project Manager, SAP GMP

South San Francisco, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $210K/yr

5+ years exp

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) focused on accelerating access to life-saving cell therapies. The Project Manager will lead cross-functional projects involving SAP implementation in GMP-regulated environments, ensuring compliance with GxP and FDA regulations while managing the project lifecycle from initiation to closure.

BiotechnologyLife ScienceManufacturingMedicalTherapeutics

Growth Opportunities

Responsibilities

Lead cross-functional projects involving SAP (ECC or S/4HANA), particularly in Supply Chain, Manufacturing, Finance and Quality modules (e.g., MM, PP, QM, WM)

Manage project lifecycle from initiation to closure, including planning, resourcing, budgeting, risk mitigation, and reporting

Ensure all projects comply with GMP, CSV (Computer System Validation), and 21 CFR Part 11 regulations

Coordinate with business and technical stakeholders to define requirements, scope, and deliverables

Manage project documentation including project charters, timelines, test plans, validation protocols (IQ/OQ/PQ), and SOPs

Serve as the liaison between IT, Quality, Regulatory, Manufacturing, and Supply Chain functions

Track and report progress to stakeholders and executive leadership; escalate risks and issues as needed

Support audits and inspections by providing relevant project documentation and participating in walkthroughs

Qualification

SAP implementationGMP regulationsProject managementERP processesPMP certificationAgile methodologiesStakeholder managementLeadership skillsCommunication skillsSelf-awareness