GMP QC Systems Lead (w2 Only )

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 & Experience8+ 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.
Key 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 & Experience8+ 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