Qualifications

• 8+ years in pharmaceutical, biotech, or GMP environments
• Strong QC/Laboratory systems implementation and validation experience
• In-depth knowledge of CSV, CSA, GAMP5, and GxP regulations
• Hands-on support experience with IQ/OQ/PQ and compliance activities
• Proven track record in managing system integrations and data migration
• Familiarity with various laboratory platforms like LIMS and Empower
• Strong skills in stakeholder management and Agile/Scrum methodologies
• Excellent communication and documentation skills

Responsibilities

• Lead GMP QC systems implementation and integration activities
• Coordinate system configuration, data migration, and stakeholder engagement
• Conduct implementation kick-off sessions and drive project execution
• Monitor project progress, risks, timelines, quality, and budgets
• Prepare status reports to ensure transparent progress tracking
• Support CSV/CSA and validation activities including IQ/OQ/PQ
• Collaborate with QA, IT, stakeholders, and vendors for regulatory compliance
• Ensure adherence to GxP, Data Integrity, and Roche standards

Benefits

• Health, dental, and vision insurance
• 401(k) retirement plan with company match
• Flexible working hours and remote work options
• Professional development opportunities
• Employee wellness programs and resources