Experience

Omeros Corporation

• United States
• Biotechnology Research
• 100 - 200 Employee

• Director, Quality Systems

  • Sep 2021 - Present

  Seattle, Washington, United States



AGC Biologics

• United States
• Biotechnology Research
• 700 & Above Employee

• Director, Quality Systems Management

  • Jan 2020 - Present

  Bothell, WA



LFB USA

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, QA Complaince

  • Jul 2017 - Jan 2020

  Provide strategic direction in the implementation of quality strategies, policies and procedures to ensure compliance, including but not limited to: • Oversight of approved supplier program • Management of internal and external audits programs • Management of regulatory inspections and client audits • Oversight of Training Management System • Responsible for ensuring timely closure of internal events (CAPA, Change Control and Deviations) and generation and distribution of Quality… Show more Provide strategic direction in the implementation of quality strategies, policies and procedures to ensure compliance, including but not limited to: • Oversight of approved supplier program • Management of internal and external audits programs • Management of regulatory inspections and client audits • Oversight of Training Management System • Responsible for ensuring timely closure of internal events (CAPA, Change Control and Deviations) and generation and distribution of Quality Metrics, including trending of Key Performance Indicators (KPI), performance of Management Reviews, and Annual Product Quality Reviews.

• Associate Director QA

  • Mar 2014 - Jun 2017

  Framingham, MA • Manage approved supplier program and ensure implementation of Quality Agreements • Manage internal and external audits programs and perform audits • Support Regulatory inspections • QA representative for the implementation of Track and Trace and Serialization program • Responsible for QA oversight of animal qualification and release of Starting Material for processing



rEVO Biologics

• Manager QA Systems

  • Apr 2012 - Jun 2014

  Framingham, MA • Maintain approved supplier program • Manage internal and external audits programs, perform audits, participate in regulatory inspection • Collaborate with departments to ensure timely closure of Deviations, Change Control, and CAPA • Develop companywide quality systems training plans • Review of analytical data used in support of regulatory submissions. • Review of test data and release of Starting Material for further processing. • Prepare Annual Product Review



GTC Biotherapeutics

• Biotechnology Research
• 1 - 100 Employee

• Associate Director, QC

  • Jun 2010 - Mar 2012

  Framingham, MA • Oversee day-to-day operations of the Quality Control laboratory with a staff of up to 10. • Ensure compliance with internal procedures and applicable regulations. • Manage internal stability programs. • Represent department on internal as well as external panning meetings. • Lead contact for CMO QC groups to support sample testing. • Support regulatory filings and inspections.

• Quality Control Group Leader

  • Apr 2006 - May 2010

  Framingham, MA • Supervise a group of five Quality Control Analysts. Prioritize and schedule testing activities. • Stability coordinator for multiple projects: Perform trending of stability data and author stability protocols and reports. • Prepared laboratory for regulatory inspections and participate in regulatory inspections. • Author, revise and approve SOPs, assay transfer protocols and reports and others as required. • Review of release and stability data.