Monica Byrd

About Monica Byrd

18 years of professional experience in quality management and laboratory operations in the Blood and Plasma industries. Key areas of expertise are:Quality ManagementGMP auditing Deviation Management and Change Management Software and Hardware ValidationEU and FDA regulations related to Blood and Plasma ProductsInteraction with European regulatory authorities

Experience

1. Senior Director, Regulatory Affairs and Quality Assurance

   Octapharma Plasma, Inc.

   Oct 2013 — Present

   Represent the Company in all regulatory-related and quality-related issues.Establish quality systems, policies, objectives, initiatives and organizational structures that support the organization’s global quality reputation.Develop strategic regulatory and quality plans to support the company business plan.P&L responsibility for the Charlotte Testing Laboratory and Plasma Storage Warehouse Operations.Develop and implement the strategic leadership for the Charlotte Testing Laboratory, both in-sourced and outsourced testing.Responsible for managing the company regulatory applications, including applications for product/process approval, licensure or certification between the company and U.S. FDA and EU regulatory/compliance agencies.Responsible for the oversight of the internal audit group to ensure effective policies and practices are in place.Develop and implement a robust tracking and trending process in order to provide data to the organization to improve overall quality processes.Develop and implement a robust process for customer notifications resulting from Lookbacks and/or deviations, ensuring that all notifications meet specified timelines.Develop and implement a robust process for company equipment and process validation requirements.Establish and lead the cross functional quarterly quality review meetings to ensure effective communication and drive quality improvements throughout the organization.Provide leadership and guidance to the Change Control Board. Oversee preparation, editing, and revisions of standard operating procedures and policies based on identified process improvements and/or changes in regulatory requirements.Overall accountability for logistics, production planning, inventory, facilities, customer operations and purchasing.

Education

• University of Phoenix

  Master of Business Administration (M.B.A.)

  2005 — 2007

• Emory University

  Bachelor's degree, Biology, General

  1989 — 1993

Skills

• Medical Devices
• Capa
• Quality Assurance
• 21 Cfr Part 11
• Gmp
• Quality Management
• Cross-Functional Team Leadership
• Regulatory Affairs
• Fda Gmp
• Validation
• Quality System
• V&V
• Biotechnology
• Change Control
• Sop
• Fda
• Gxp
• Quality Auditing