Experience

Agios Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Associate Director, Head of Digital Quality and Data Integrity

  • Jun 2021 - Present

  Responsible to help ensure Agios selects, implements, and maintains GXP computer systems in compliance with US, MHRA and EMA regulations and industry best practices.Define the strategy and provide QA oversight of computer systems validation and audit activities. Support the data integrity, IT security, and risk management of computer systems.

• Sr. Manager, Digital Quality and Data Integrity

  • Jan 2020 - Jun 2021



Spark Therapeutics, Inc.

• United States
• Biotechnology
• 700 & Above Employee

• Sr. IT CSV Specialist - R&D and Quality (Consultant)

  • Oct 2019 - Jan 2020



BioTissue

• United States
• Biotechnology Research
• 100 - 200 Employee

• IT CSV Lead - R&D (Consultant)

  • Mar 2019 - Sep 2019

  Authored CSV Deliverables for a variety of Laboratory Systems, using GAMP5 guidance. Systems Included - Standalone Systems (Spectrophotometers and Microscopes). Custom/Bespoke Lab Supplies System Enterprise Systems (ComplianceBuilder) Implementation of Part 11 Supplemental Interface solution for deficient (21 CFR Part 11/Data Integrity) standalone lab systems/software Managed Validation Non-Conformances, identified root cause and corrective actions for closure Generated System Administration/Maintenance SOPs & Operational End User System SOPs Project Managed CSV Deliverables as a “liaison” for Laboratory Department working with IT & QA Departments Managed weekly lab system meetings w/ clients, meeting minutes/action items distribution to project team Reported progress/dashboards to senior management Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• IT CSV Lead- IT Quality and Compliance (Consultant)

  • Nov 2015 - Jan 2019

  IT CSV/QA Lead on assigned projects, responsible for the creation, execution and coordination of the project’s deliverables using tools like ValGenesis, Documentum and MS Visual Studio (now known as Azure DevOps) in an Agile environmentManaged 3-5 CSV/QA onshore and offshore resources including hiring and resource management.Managed and coordinated continuous improvement initiatives as related to quality systems, as required.

• Sr. IT CSV Specialist - IT Quality and Compliance (Consultant)

  • Mar 2014 - Nov 2015

  Supported the Change Control and CAPA process in TrackWise by providing technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated statusAssisted in development and distribution of computer validation policy, standards and templates using ComplianceWire which can be effectively executed by the sites and are compliant with US/EU regulatory requirementsPerformed Data Integrity Assessment (DIA) on GxP systems used across Catalent. Performed Periodic Review of several GxP critical and major applications and coordinated with the Business and IT on the gaps identified as a part of the review process. Project Summary:• Manufacturing Execution Systems (MES)• Shipment Portal• Global Scan Assembly• Agilent OpenLAB EZChrom Edition A.04.05• Proteus Ingestible Event Marker Test Station (ITS) v 2.0• In-Line Scanning System (ILSS)• Clinicopia 4.2.5.0• Global Scan Assembly Translations (The system was translated from English to several foreign languages e.g. Japanese, Spanish, Portuguese) • Thermo Scientific Portable Optical Analyzers- TruScan RM)• Label Verification System (LVS) Show less



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. CSV Specialist (Consultant)

  • Oct 2013 - Mar 2014

• CSV Specialist (Consultant)

  • Mar 2013 - Oct 2013

  Project Summary:IDBS E-Workbook (ELN) v9.3.1 (Implementation in France)Migration of the following Genzyme applications from Genzyme’s Datacenter to the Next Generation Data Center (NGDC) of Sanofi1. Clintrial 4.52. docuBridge, 3. Submission Tracker, 4. Text Verification Tool, 5. eCTD Manager, 6. gMED, 7. Argus Insight and Safety Applications, 8. ClinicopiaGenerated applicability matrix for mapping Genzyme SOP’s to Sanofi’s Quality Documents. Performed Inspection Readiness of several GxP critical and major applications like PRISMA, IRiS, gMED and eCTD Manager and worked with the Business on the gaps identified during the the process to chalk out a remediation plan for each individual application. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CSV Specialist (Consultant)

  • Apr 2012 - Mar 2013

  Involved in the validation of LabVantage SQL*LIMS v5.1 across Validation and Production environments and integration of lab equipment with SQL*LIMS using PerkinElmer LimsLink. Involved in the validation of LabVantage SQL*LIMS v5.1 across Validation and Production environments and integration of lab equipment with SQL*LIMS using PerkinElmer LimsLink.



Eli Lilly and Company

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Research Associate

  • Aug 2010 - Mar 2012

  Designed and Validated Micro mill to study the breakage pattern of the particles using single impact. Gathered requirements and developed a model that describes breakage behavior without separating grinding and classifying processes to study particle hardness and fracture toughness in a Spiral Jet Mill. Developed a model that predicts the milling behavior using limited consumption of high value active pharmaceutical ingredients (API) for a project sponsored by Eli Lilly. Performed testing to analyze the particle size and the Particle Size Distribution (PSD) of the feed and the final product using Beckman Coulter LS 13 320 to characterize optimum milling conditions. Responsible for ensuring compliance of GLP and GCP regulations and Part 11. Show less