Idalia Lopez
Senior Document Control Specialist, Gene Therapy Research Engineering @Astellas Pharma
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WORK HISTORY
Senior Document Control Specialist, Gene Therapy Research Engineering @Astellas Pharma
SKILLS
ABOUT IDALIA LOPEZ
Results-driven Records and Information Management leader with 20+ years of experience in regulated life sciences environments, currently serving as a Senior Document Control Specialist leading global, multi-site Document Control and RIM programs.Bringing deep institutional knowledge and proven expertise in Document Control governance, EDMS (Veeva) administration, GxP compliance (21 CFR Part 11), records lifecycle management, and inspection readiness, I specialize in building and sustaining compliant, scalable systems that support business-critical operations.Recognized for strong ownership of enterprise document control systems, I have successfully implemented and harmonized processes across global, multi-site organizations. I am a trusted, collaborative partner to cross-functional teams, known for driving alignment, ensuring compliance, and delivering operational excellence through process optimization, continuous improvement, and data-driven decision-making.As an experienced people leader, I am passionate about developing high-performing teams through strategic hiring, structured onboarding, impactful training, and ongoing mentorship. I lead with adaptability and accountability, staying responsive to evolving business needs while fostering a culture rooted in quality, compliance, and continuous growth.
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