Validation Lead

The Validation Lead is responsible for leading the implementation, integration, and validation of GMP Quality Control and laboratory systems within a highly regulated pharmaceutical or biotechnology environment. The role oversees system configuration, data migration, deployment, testing, and validation activities while ensuring compliance with GxP, Data Integrity, CSV/CSA, GAMP 5, and applicable regulatory requirements.

• 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.
• 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.