Grace Halteh, M.S., Pmp
About Grace Halteh, M.S., Pmp
Grace Halteh, M.S., PMP, serves as the Vice President of Quality at Arcellx, Inc., where she has worked since 2021. With extensive experience in quality management within the pharmaceutical industry, she has held various leadership roles at notable companies, including Genentech, Elan Pharmaceuticals, and Jazz Pharmaceuticals.
Current Role at Arcellx
Grace Halteh serves as the Vice President of Quality at Arcellx, Inc. since 2021. In this role, she is responsible for overseeing quality management systems and ensuring compliance with industry standards. Her leadership focuses on maintaining high-quality standards in the development and manufacturing processes, contributing to the company's commitment to delivering safe and effective therapies.
Previous Experience in the Pharmaceutical Industry
Grace Halteh has held various significant positions in the pharmaceutical sector. She worked at Genentech - Roche as Operations Business Excellence Lead for one year from 2013 to 2014. Prior to that, she was the Associate Director of Quality Systems at Elan Pharmaceuticals for eight years, from 2001 to 2009. Her experience also includes roles at Exelixis, Nektar Therapeutics, Jazz Pharmaceuticals, and Janssen Alzheimer Immunotherapy, where she contributed to quality management and operational excellence.
Education and Certifications
Grace Halteh holds a Master of Science (M.S.) degree in Systems Management. She also earned a Bachelor of Science (B.S.) degree in Cell and Molecular Biology. Additionally, she has achieved Project Management Professional (PMP) certification from PMI, which underscores her expertise in project management within the life sciences sector.
Expertise in Quality Management
Grace Halteh has recognized expertise in developing and implementing audit programs and inspection readiness strategies. She specializes in operational assessments and process improvement in the life sciences sector. Her extensive experience includes managing Quality Systems and Trial Master Files (TMF), contributing to the global registration of both Biologics and Small Molecules products.
Training and Development Initiatives
Throughout her career, Grace Halteh has developed and led training programs focused on quality management and compliance. These initiatives aim to enhance the understanding and implementation of quality standards across organizations, ensuring that teams are well-equipped to meet regulatory requirements and industry best practices.