Jarusha Bonitz

Background

About Jarusha Bonitz

I am exceptional professional in Quality Assurance with 25 years in the pharmaceutical industry in contract manufacturing and generics organizations with compliance experience in a variety of dosage forms (tablets, capsules, soft gel, liquid, topical, sterile, etc.) and medical device/drug combination products. I have over 10 years of experience in Quality Management with a focus on global GMP compliance and Quality Management Systems and Laboratory Systems. With primary responsibility for regulatory inspection management at multiple FEIs and international sites, I have led over 35 regulatory inspections by the USFDA and international Health Authorities in both the US and UK, resulting in over 60 product approvals, and have been the primary corporate advisor on regulatory compliance for a multi-site organization. I also led global remediation initiatives to successfully overcome a restricted EU GMP Certificate and Statement of Non-Compliance and to fully regain EU GMP Certification. In addition to regulatory inspection management, I managed several QA teams with responsibility for Client Audits, Internal Audits, and the Supplier/Vendor Qualification Program, including external qualification audits of API, excipient and packaging component manufacturers and contract testing laboratories. My degree in Chemistry and ten years of experience in a cGMP laboratory environment has provided a solid foundation for my contributions to quality and compliance. My approach to ensuring quality and organizational excellence employs risk management techniques to balance business needs and compliance to attain timely delivery of quality pharmaceutical products while ultimately ensuring patient safety. I am dedicated to identifying innovative solutions to implement continuous improvement and developing and establishing a quality culture across all levels of an organization in order to achieve and maintain a state of sustainable compliance.