Charles Landry Email and Phone Number

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.

* Responsible for all aspects of Account Service* Interact on a regular basis with client personnel regarding program operation, goals and successes, and instill customer confidence in our program and personnel* Provide business review reports of the program to the client in an approved format and professional manner.* Assure that the inventory list is current, accurate, and complete through ongoing inventory activities.* Responsible for Service Event Management* Responsible for accurate data input to Asset Management database, i.e. service requests, work orders and purchase order information.* Monitor PM activity through PM management reports to assure timeliness and completion.* Communicate in a timely fashion with vendors and client contacts to resolve service or billing issues, questions or credits. Utilize poise, tact, diplomacy, and negotiation skills to obtain cooperation and results* Receives and manage customer service requests for installations, relocations, calibrations, preventive maintenance and basic repairs. Ensures that the schedule meets the customer’s needs. Communicate schedule of services on a daily basis.* Reports daily activities in SAP or Customer Support Administration department for accurate record keeping, including closing service calls upon completion.* Maintains personal Field Service inventory of replacement parts. Returns defective material in a timely manner, and orders replacements in accordance with company policy.

10/07-Present CDAS Senior Administrator* Project Manage and execute the Atlas Chromatography Data Acquisition system validation upgrade (Thermo Fisher Atlas® version 8.2)* Manage the current Chromatography Data Acquisition system (Thermo Fisher Atlas® version 2003 R2). Responsibilities include: * Manage the CDAS Servers. * Manage the Chromatography Instruments through the Instrument Manager application.* Manage the Client Server Configurations.* Manage the Chromatography Servers and DataServers/Instrument Controllers. * Manage end user and menu settings. * Perform periodic audits of the system. * Maintain the CDAS Standard Operating Procedures.

*Performed Calibration Lab Testing, which includes Liquid Scintillation Counting, Gamma Spectroscopy, Gamma Counting, Inductively Coupled Plasma Spectroscopy, and Kiethley 4Pi Assay. * Classified as a Radiometrics "Super User" for Inductively Coupled Plasma Spectroscopy and the Chromatography Data Acquisition System.* Member of Chromatography Data Acquisition Validation Team. * Performed all Sr. Technologist testing and project management.* Independently managed various key projects for Radiometrics, in addition to performing all final product testing. * Classified as a Radiometrics "Super User" for HPLC, Graphite Furnace Spectroscopy and the Multi Chromatography Data Acquisition System. Key Projects include: * Managing Instrument Validations, Protocols.* Maintenance and Calibration Program for all Radiometrics’ Analytical Instrumentation.* Performed Final product testing of Nuerolite™/Cardiolite™ including radiolabeling & RCP determination by HPLC and TLC.

* Program Manage the BMSMI Nuclear Energy Institute-NIST Traceable and Isotope Secondary Standards Program: Which includes the NIST program, BMSMI In-house program, Quality and Manufacturing’s Capintec Calibration and Linearity programs and Annual Efficiency Verification programs for HPGe detectors, NaI detectors and Liquid Scintillation Counters. Manage the Quality Control Radiation Detector System, ICP Lab and Alpha Analyst Spectroscopy System. * Project Manage instrument and/or methods validations as needed.* Perform daily Calibration & ICP Lab testing which includes Liquid Scintillation Testing, Gamma Spectroscopy, Gamma Counting, Inductively Coupled Plasma Spectroscopy, and Keithley 4pi Assay. * Classified as a Radiometrics "Super User" for Inductively Coupled Plasma Spectroscopy and the Chromatography Data Acquisition System.* Member of Chromatography Data Acquisition Validation Team.