Senior GMP QC Systems Lead: Implementation & Validation

Katalyst CRO; Frankford (DE); On-site; USD 130,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a seasoned professional to lead implementation and integration of GMP QC systems. You will coordinate configuration, data migration, deployment, and stakeholder engagement to ensure compliant, on-time delivery.

Responsibilities include kick-off sessions, progress monitoring, risk and budget management, and support for CSV/CSA validation activities. Collaboration with QA, IT, and vendors is essential to ensure regulatory compliance and release readiness.

Qualifications

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments.
• Experience with QC/Laboratory systems implementation and validation.
• Knowledge of CSV, CSA, GAMP5, and GxP regulations.

Responsibilities

• Lead implementation and integration activities for GMP QC systems.
• Coordinate system configuration, data migration, deployment, and stakeholder engagement.
• Conduct implementation kick-off sessions and drive project execution; monitor progress, risks, timelines, quality, and budget.
• Prepare status reports and ensure transparent progress tracking; support CSV/CSA and validation activities with IQ/OQ/PQ documentation.
• Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance and release readiness.

Skills

GxP compliance

Stakeholder management

Project coordination

Agile/Scrum

Regulatory compliance

IQ/OQ/PQ execution

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

Katalyst CRO is seeking a seasoned professional to lead implementation and integration of GMP QC systems. You will coordinate configuration, data migration, deployment, and stakeholder engagement to ensure compliant, on-time delivery.

Responsibilities include kick-off sessions, progress monitoring, risk and budget management, and support for CSV/CSA validation activities. Collaboration with QA, IT, and vendors is essential to ensure regulatory compliance and release readiness.