Validation Lead
Katalyst CRO · Hillsboro, OR · 2 days ago
On-siteQuality AssuranceContract
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
- 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.