8+ years in pharma, biotech, or regulated GMP environments
Expertise in QC/Laboratory systems implementation and validation
Familiar with CSV, CSA, GAMP5, and GxP regulations
Hands-on experience with IQ/OQ/PQ, risk assessments, and compliance
Proven capability in managing data migration and system integrations
Strong stakeholder management and Agile/Scrum experience
Excellent communication and documentation skills
Responsibilities
Lead the setup and integration of GMP QC systems
Coordinate configuration, data migration, and stakeholder engagement
Conduct project kickoff sessions and oversee execution
Monitor project details including risks, timelines, and quality
Prepare regular status updates and track project progress
Support and validate compliance activities alongside QA and IT
Ensure standards for GxP, Data Integrity, and Roche validation are met
Benefits
Comprehensive healthcare coverage
Potential for career development and training
Flexible working arrangements
Opportunity to work with leading-edge technology
Collaborative and supportive team environment
Full 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.
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
