Experience

Arcus Biosciences

• United States
• Biotechnology
• 300 - 400 Employee

• Director, QA & Compliance

  • Feb 2022 - Present



Seattle Genetics

• Bothell, Washington, United States

• GCP Consultant

  • Jun 2021 - Dec 2021

  • Conduct remote and hybrid GCP audits of investigational sites, SMO, vendor and internal process • Present GCP and regulatory compliance perspectives for Clinical Operations • Perform gap analysis of internal systems, policies and procedures to ensure that all processes are in compliance with ICH GCP (E6) guidelines and federal regulations. Provide root cause analysis of existing system deficiencies and solutions for processes improvement • Development and Review of GCP QA Audit Program, Quality Metrics and Quality System Improvements • Report on CAPA trends, common root cause, effectiveness checks and areas of improvement and in close collaboration with other QA, internal and external stakeholders Show less



Advarra

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• GCP Consultant

  • Mar 2021 - May 2021

  Conduct GCP audits of investigational sites Conduct GCP audits of investigational sites



Espirion Therapeutics

• Ann Arbor, Michigan, United States

• Associate Director, GCP QA & Compliance

  • Jul 2020 - Feb 2021

  Esperion Therapeutics, Ann Arbor, MI, USA • Manage multiple clinical projects, plan and schedule various domestic and international GCP audits of internal systems, clinical investigational sites and third-party vendors including CROs, and SMO’s. Ensure appropriate audit output - audit reports, analyze audit responses and manage CAPAs. Analyze and trend audit observations • Develop and implement policies, SOP’s and WI for GCP compliance programs, provide GCP compliance oversight across Espirion’s different systems and processes to ensure compliance with applicable regulations and guidelines. • Perform gap analysis of internal systems, policies and procedures to ensure that all processes are in compliance with ICH GCP (E6) guidelines and federal regulations. Provide root cause analysis of existing system deficiencies and solutions for processes improvement • Participate in clinical team meetings; provide Clinical Operations with expert GCP advise for compliance related tasks and programs • Present GCP and regulatory compliance perspectives for Clinical Operations and investigator/site staff at investigator meetings and other internal functions such as project kick-off/clinical/management meetings • Conducting GCP audits: Investigator Sites, Clinical vendor/CRO/SMO, Systems, Project, CSR, TMF, Phase 1 Units, clinical databases, etc. Provide GCP training • Inspection Readiness Training for Investigator Sites/Vendors/CROs and Sponsor/CROs • Assist in facilitation of regulatory agency inspections, lead for-cause, external and third-party audits • Review of Clinical Study Documents (protocols, Informed Consents, Operating Guidelines, Case Report Forms, Investigator Brochures, Monitoring Plans, etc.) • Development and Review of GCP QA Audit Program, Quality Metrics and Quality System Improvements. Show less



AstraZeneca, USA

• Morristown, NJ, USA

• Associate Director, GCP QA & Compliance

  • Apr 2012 - Jul 2020

  • Manage multiple clinical projects, plan and schedule various domestic and international GCP audits of internal systems, clinical investigational sites and third party vendors including CROs. Ensure appropriate audit output - audit reports, analyze audit responses and manage CAPAs. Analyze and trend audit observations; • Participate in establishing and maintenance of companywide GCP compliance programs, provide GCP compliance oversight across Pearl’s different systems and processes to ensure compliance with applicable regulations and guidelines. Assist in development and implementation of Pearl's GCP compliance strategy; • Perform gap analysis of internal systems, policies and procedures to ensure that all processes are in compliance with ICH GCP (E6) guidelines and federal regulations. Provide root cause analysis of existing system deficiencies and solutions for processes improvement; • Participate in clinical team meetings; provide Clinical Operations with expert GCP advise for compliance related tasks and programs; • Present GCP and regulatory compliance perspectives for Clinical Operations and investigator/site staff at investigator meetings and other internal functions such as project kick-off/clinical/management meetings. • Assist in facilitation of mock inspections, external, third-party audits and regulatory inspections; • Maintain training file system for Pearl NJ office employees. Assist in development and revision of departmental and cross departmental SOPs. Maintain and support NJ office SOP system. • Provide training on GCP audit, compliance and inspection techniques to existing QA personnel. Provide oversight and management of contractors on PRN basis. Show less



PharmaNet Development Group, Inc.

• Princeton, NJ, USA

• Clinical Data Analyst

  • Nov 2005 - Jun 2011

  • Performed data review and query generation • Defined edit checks to be programmed for the study/project, reviewed programmed edit checks • Tracked study progress and issued periodic status reports, updated the database to correct errors • Processed electronic data received from outside vendors • Participated in the completion of all quality control measures necessary for the finalization and transfer of the database and related materials to the sponsor • Coordinated work of Associate Data Analysts assigned to the project, provided training on data management procedures and systems • Created data management plans for various projects, performed review of various database designs • Developed and designed CRFs • Developed and revised departmental and cross departmental SOPs Show less



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CDM

  • 2004 - 2005