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
Numbers & Facts
Location
Annapolis, MD
Skills
Agile Programming Methodologiesunmatched
Biotech and Pharmaceuticalunmatched
Budgetingunmatched
Communication Skillsunmatched
Computer Systemsunmatched
Control Engineeringunmatched
Cross-Functionalunmatched
Data Migrationunmatched
Data Qualityunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Systemsunmatched
Maintain Complianceunmatched
Organizational Skillsunmatched
Process Validationunmatched
Project Executionunmatched
Project Trackingunmatched
Project/Program Coordinationunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Regulationsunmatched
Reporting Skillsunmatched
Risk Analysisunmatched
Scientific Data Management System (SDMS)unmatched
Scrum Project Management and Software Developmentunmatched
Status Reportsunmatched
System Integration (SI)unmatched
System Validationunmatched
Systems Administration/Managementunmatched
Testingunmatched
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