Charles Landry
Associate Director Quality and Data Integrity Gmp @Vertex Pharmaceuticals
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WORK HISTORY
Associate Director Quality and Data Integrity Gmp @Vertex Pharmaceuticals
As the Associate Director, Quality and Data Integrity - GMP, I work closely with the Operational and Quality functions to support computerized systems used in Quality Control (QC) and Release and Stability Laboratories (RSL) at Vertex Pharmaceuticals. I am responsible for developing and implementing an effective and tailored Data Integrity quality management system for systems used in these areas. My overall goal for this role is to work collaboratively with cross functional teams to facilitate end-to-end business processes, identify potential data integrity risks and provide expertise in developing mitigation strategies. I am responsible for ensuring the above programs and underlying activities are conducted using GxP aligned risk- based methodologies that assure adherence to applicable regulations, industry standards, Vertex policies, procedures and quality standards as set forth in the Quality Management System. I ensure seamless integration of defined policies, standards, and best practices, across the GMP areas and functions pertaining to computer systems quality and data integrity. I am responsible for engaging at the project and program level to identify, assess, and prioritize gaps and risks leveraging GxP knowledge and in collaboration with Quality operations and Business leaders and SMEs. I provide risk- based and phase-based direction to the Data Integrity program and in addition will oversee risk mitigation action plans including corrective and preventive actions.
EDUCATION
Middlesex Community College
Associates, Liberal Arts and Science
SKILLS
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