Arlene Christensen
About Arlene Christensen
Arlene Christensen is the Associate Director of Quality Assurance at Aimmune Therapeutics, where she has worked since 2019. With extensive experience in quality assurance across various companies, she has a strong background in establishing quality systems and transitioning products through regulatory approval.
Current Role at Aimmune Therapeutics
Arlene Christensen serves as the Associate Director of Quality Assurance (cGMP) at Aimmune Therapeutics, a position she has held since 2019. In this role, she is responsible for overseeing quality assurance processes to ensure compliance with current Good Manufacturing Practices (cGMP). Her work is critical in maintaining the integrity of the quality systems within the organization, which supports the development and commercialization of therapeutics.
Previous Experience in Quality Assurance
Prior to her current position, Arlene Christensen accumulated extensive experience in quality assurance across several organizations. She worked at Cellerant Therapeutics as Associate Director of QA Operations from 2013 to 2019. Before that, she held the role of Sr QA Program Manager at Affymax for four months in 2012 and served as Associate Director of Quality Assurance at Affymax from 2008 to 2012. Her earlier roles include QA Manager at Telik, Inc. and QA Supervisor at Elan Pharmaceuticals.
Educational Background
Arlene Christensen earned her Bachelor of Science degree from the University of California, Davis, where she studied from 1985 to 1990. This educational foundation has equipped her with the knowledge necessary to excel in the field of quality assurance and regulatory compliance within the biotechnology and pharmaceutical industries.
Expertise in Quality Systems
Arlene Christensen possesses significant expertise in establishing and improving quality systems for a variety of product types, including cell therapy, biologics, synthetic peptides, small molecules, and antibody-drug conjugates. She has successfully transitioned two products from late clinical phases through regulatory approval and into commercial launch, demonstrating her capability in managing complex quality assurance processes.
Interpersonal Skills and Collaboration
Arlene Christensen is recognized for her strong interpersonal skills and her ability to collaborate effectively across functions. She ensures that GMP records are maintained in a clear, concise, and defensible manner, which is essential for compliance and operational efficiency in the quality assurance domain.