Senior GMP Validation Lead – QC Systems & CSV

Katalyst-Healthcares-; Hillsboro (OR); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC seeks an experienced leader to drive GMP QC systems implementation and validation across labs and manufacturing. You will coordinate configuration, data migration, deployment, and stakeholder engagement to ensure timely deliverables.

Responsibilities include IQ/OQ/PQ support, risk assessments, testing, and ensuring regulatory compliance with QA, IT, and vendor partners for a successful go-live.

Qualifikationen

• 8+ years in pharma/regulated GMP environments.
• Strong experience with QC/Lab 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 project delivery.
• Familiarity with laboratory platforms such as LIMS, SDMS, Empower, SoftMax Pro, QuantStudio, LabX, or similar systems.

Aufgaben

• 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.

Kenntnisse

GMP experience

QC systems

CSV/GxP knowledge

IQ/OQ/PQ execution

System integrations

Stakeholder management

Documentation

Tools

LIMS

SDMS

Empower

SoftMax Pro

QuantStudio

LabX

Jobbeschreibung

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.