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

Roles & 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.

Roles & 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.

Required Skills

• 8+ years of experience in pharmaceutical, biotech, or regulated GMP environments.
• Strong experience with QC/Laboratory systems implementation and validation.
• Knowledge of Computer System Validation (CSV), CSA, GAMP5, and GxP regulations.
• Hands-on experience supporting IQ/OQ/PQ, risk assessments, testing, and compliance activities.
• Experience managing system integrations, data migration, and cross-functional project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.
• Strong stakeholder management, Agile/Scrum, and project coordination skills.
• Excellent communication and documentation capabilities.