Amie Kirschner, Asq Cqa
About Amie Kirschner, Asq Cqa
Amie Kirschner is the Clinical Development QA Operations CAR T/Cell Therapy Senior Manager at Bristol-Myers Squibb in Warren, New Jersey, with extensive experience in quality assurance for cellular therapies.
Current Role at Bristol-Myers Squibb
Amie Kirschner serves as the Clinical Development QA Operations CAR T/Cell Therapy Senior Manager at Bristol-Myers Squibb in Warren, New Jersey. In this role, she oversees the quality assurance aspects of both marketed and clinical cellular therapies. Her work focuses on ensuring compliance with cGMP requirements and the Novartis Quality Manual, emphasizing quality culture and data integrity. Kirschner is also responsible for managing the manufacturing, packaging, and testing processes for various products, including oral solid dosage, aseptic/liquid, biopharmaceutical, and combination products.
Previous Experience at Novartis and Sandoz
Before joining Bristol-Myers Squibb, Amie Kirschner worked at Novartis and Sandoz in various roles. From 2017 to 2019, she was involved in Global QA Compliance as part of the Platform and Country Oversight for ESO Americas. Prior to that, she spent a year as Quality Systems and Compliance Manager for External Supply Operations at Sandoz. Between 2011 and 2015, Kirschner held the position of Internal Audit Lead/Inspection Management/Quality Manual Coordinator within the Regulatory Compliance Group at Novartis Pharma Ops. Her experience in these roles has given her extensive expertise in regulatory compliance and health authority inspection management.
Education and Professional Development
Amie Kirschner's educational background is rooted in the sciences, having earned a BS in Chemistry with a minor in Psychology from Rensselaer Polytechnic Institute. She also attended the Graduate School of Biomedical Sciences at the University of Medicine and Dentistry of New Jersey. Kirschner has pursued continuing professional education over a span of 10 years, focusing on pharmaceutical professional development. Additionally, she achieved certifications related to investigatory, reviewer, and approver roles for deviations, complaints, and laboratory processes during her time at Novartis PharmOps.
Early Career and Experience at Roche and Glatt Group
Kirschner’s early career included an extensive 14-year tenure at Roche as a QA Compliance Specialist, followed by a five-year period at Glatt Group as the Quality Assurance Group Leader for the Pharmaceutical Services Division. During her time at these organizations, she honed her skills in managing quality systems and compliance, which laid a strong foundation for her subsequent roles in the pharmaceutical industry. Her extensive experience makes her proficient in various analytical techniques and cGMP documentation design and process development/validation practices.
Expertise in Quality Assurance and Collaborative Management
Amie Kirschner is recognized for her collaborative interpersonal style and proven management and team-building abilities. She excels in third-party and contract manufacturing oversight, and she is adept at tracking Key Quality Indicators (KQIs) against quality plan targets. Her role frequently involves establishing communication channels with entities that manage suppliers for finished products, bulk, packaging operations, API, and intermediates. Kirschner also serves as a Subject Matter Expert (SME) in ESO QA projects, driving the implementation of procedures across multiple platforms.