Jennifer Schneller

Experience

• 

  Abbott

  Jan 2005 - Jan 2013

  Accountable for overall quality leadership and decision-making for Regulatory Affairs Quality System documentation control and capital initiative support. Demonstrates comprehensive understanding of the regulatory business model. Accountable for compliance with applicable regulations and policies. Collaborates with and provides recommendations to IT, Initiative Management Office, Program Team, and regulatory personnel regarding regulatory quality compliance. Manage the Global Pharmaceutical Regulatory Affairs Quality System program and process improvement initiatives to strengthen the organization through standards and overall quality approach. • Facilitated interactions for Global Pharmaceutical Regulatory Affairs during regulatory inspections• Lead various Process Improvement Projects• Managed local quality system program and support development of associated training strategies• Managed Standard Operating Procedure Design and Control Strengthened QA assessment, management and mitigation of BSE/TSE risk to Abbott API, Drug Products and Commodities; Assessed compliance to BSE/TSE regulations and Corporate policies; Streamlined, standardized, and proceduralized BSE/TSE survey process; Functioned as a Business System Analyst in the establishment of Compliance Inspection Tracking tool; Assisted Supplier QA in a future system strategy.

  • Director, Quality Systems, Regulatory Affairs

    Aug 2012 - Jan 2013

  • Associate Director

    Aug 2009 - Aug 2012

  • Manager, Quality Systems

    May 2007 - Aug 2009

  • QA Project Manager

    Jan 2005 - May 2007
• 

  AbbVie

  Jan 2013 - now

  Ensuring clinical studies are successfully implemented through a strong foundation of GCP Compliance, governing quality system documentation, and quality control of processes supporting over 2500 colleagues within the Development organization. Accelerating patient impact by delivering operational services and driving efficiencies to meet evolving business needs through collaborative partnerships, new ideas, and innovative approaches. Serving as a trusted partner within Regulatory and R&D Quality Assurance to implement innovative solutions andremove operational barriers, enabling stakeholders to focus on their core business objectives. Accountable for overall leadership and decision-making for Regulatory Affairs, R&D Quality Assurance, and Safety Quality System documentation change control, compliance training, and capital initiative support. Business System Owner of AbbVie's Business Process Analytics application. Accountable for overall quality leadership and decision-making for Regulatory Affairs Quality System documentation control and capital initiative support. Demonstrates comprehensive understanding of the regulatory business model. Accountable for compliance with applicable regulations and policies. Collaborates with and provides recommendations to IT, Initiative Management Office, Program Team, and regulatory personnel regarding regulatory quality compliance.

  • Director, Clinical Process Compliance

    Jan 2020 - now

  • Interim Head, RQ Shared Services Director, Business and Compliance Services

    Sept 2019 - Jan 2020

  • Director, RQS Compliance Operations

    Dec 2015 - Sept 2019

  • Director, Quality Systems, Regulatory Affairs

    Jan 2013 - Dec 2015