8+ years in pharmaceutical, biotech, or GMP environments
Strong background in QC/laboratory systems implementation and validation
Deep knowledge of CSV, CSA, GAMP5, and GxP regulations
Hands-on experience with IQ/OQ/PQ processes and compliance activities
Experience in managing data migration and cross-functional project delivery
Familiarity with laboratory platforms such as LIMS and Empower
Strong stakeholder management and Agile/Scrum skills
Responsibilities
Lead GMP QC systems implementation and integration activities
Coordinate system configuration and data migration efforts
Conduct project kick-off sessions and oversee execution
Monitor project progress, risks, timelines, and quality adherence
Prepare status reports and ensure transparent progress tracking
Support validation activities and collaborate for regulatory compliance
Ensure adherence to GxP, Data Integrity, and validation standards
Benefits
Engagement with cutting-edge pharmaceutical technology
Opportunities to lead high-impact projects
Collaboration with cross-functional teams and stakeholders
Emphasis on regulatory compliance and best practices
Participation in the continuous improvement of quality systems
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
