Senior GMP QC Systems Validation Lead

Katalyst CRO; Hillsboro (OR); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced professional to lead the implementation and integration of GMP QC systems in a regulated environment. You will coordinate configuration, data migration, and stakeholder engagement while driving project execution and ensuring compliance with CSV/CSA and GxP standards.

Responsibilities include managing risks, tracking budgets, and guiding IQ/OQ/PQ activities, collaborating with QA, IT, and vendors to achieve go-live readiness.

Qualifications

• 8+ years in pharmaceutical, biotech, or regulated GMP environments.
• Strong experience with QC/Laboratory systems implementation and validation.
• Knowledge of CSV, CSA, GAMP5, and GxP regulations.
• Hands-on IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional delivery.

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 project progress, risks, timelines, quality, and budget adherence.
• Prepare status reports and ensure transparent progress tracking.
• Support CSV/CSA and validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate with QA, IT, business stakeholders, and vendors to ensure regulatory compliance.
• Ensure adherence to GxP, Data Integrity, and Roche validation standards.
• Support system acceptance, release readiness, and go-live activities.

Skills

GMPExperience

LabSystemsValidation

CSV/CSA/GxP

IQ/OQ/PQ

SystemIntegration

LabPlatforms

StakeholderManagement

Communication

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Job description

Katalyst CRO is seeking an experienced professional to lead the implementation and integration of GMP QC systems in a regulated environment. You will coordinate configuration, data migration, and stakeholder engagement while driving project execution and ensuring compliance with CSV/CSA and GxP standards.

Responsibilities include managing risks, tracking budgets, and guiding IQ/OQ/PQ activities, collaborating with QA, IT, and vendors to achieve go-live readiness.