Antoinette Ryan

About Antoinette Ryan

I am a seasoned Quality Assurance leader with over 22 years of experience across highly regulated industries, including Pharmaceuticals, Medical Devices, Biologics, and Food Science. I am passionate about driving operational excellence by optimizing quality systems to ensure full regulatory compliance, while fostering continuous improvement initiatives that reduce costs, mitigate risks, and enhance product quality.With a strong track record of building and leading high-performing, cross-functional teams, I am dedicated to cultivating a culture of compliance and aligning team efforts with organizational goals. My approach is results-driven, focused on achieving strategic objectives while maintaining the highest standards of quality and safety.I possess a deep understanding of Biotechnology, Lean Six Sigma methodologies, FDA regulations, HACCP, Food Safety, and Corrective and Preventive Action (CAPA). My experience enables me to navigate complex regulatory landscapes and deliver impactful solutions that meet both compliance and business objectives.I am committed to using my knowledge and expertise to drive continuous improvement and deliver lasting value in every project I undertake.

Experience

1. Vice President Quality Assurance

   Controlled Contamination Services

   Jan 2024 — Present

   Manage and maintain ISO 9001:2015 ISO certification for organization.Quality oversite for all regions across United States (West, Central and East)Manage a team of 7 across U.S.Manage and maintain QMS (Corrective Actions, internal and external audit programs, suppliers, calibration, document control, Standard Operating Procedures, Quality Agreements)Manage and maintain LMS and training for organization via Learning management system (GMP, ISO 9001, OSHA, Leadership, Cleanroom environments, FDA.)Oversite of Environment Health and Safety and responsible for ensuring compliance with OSHA requirements.Work with and support clients across United StatesMaintain budget of over $1.2 millionAccomplishments:Created a Leadership/Management Training Program.Restructured and enhanced the organization\'s training matrix to prioritize regulatory requirements, HR guidelines, and job-specific criteria. Achieved a 30% reduction in average training assignments.Transformed the QA department into a revenue-generating entity by providing EHS and GMP training services to clients.

Education

• UIC

  BS, Biology

  1997 — 2001

Skills

• Gmp
• Pharmaceutical Industry
• Sop
• Fda
• Capa
• Biotechnology
• Quality Control
• Leadership
• Lean Six Sigma
• Team Management
• Change Management
• Food Science
• Haccp
• Sqf