Jason Bilobram is a seasoned expert in Quality Systems, Regulatory Affairs, and Compliance strategy, currently serving as the Owner and Principal Consultant at Quality Management Solutions. With a robust background in the medical device, in vitro diagnostics (IVD), and pharmaceutical industries, Jason has cultivated a...
Jason Bilobram is a seasoned expert in Quality Systems, Regulatory Affairs, and Compliance strategy, currently serving as the Owner and Principal Consultant at Quality Management Solutions. With a robust background in the medical device, in vitro diagnostics (IVD), and pharmaceutical industries, Jason has cultivated a reputation as an innovative and strategic leader. His role encompasses acting as the Director of Quality and Regulatory Affairs, overseeing Risk Management Programs, and coordinating FDA inspection responses, ensuring that organizations navigate the complex landscape of regulatory compliance with confidence.
At Quality Management Solutions, Jason leads key projects focused on the implementation of globally compliant Quality Management Systems (QMS), enabling clients to meet stringent regulatory requirements across multiple regions, including the US, Canada, Europe, and Asia. His expertise in regulatory submissions is complemented by his skills in technical documentation, validation processes, and complaint management, which are critical for successful product launches and ongoing compliance.
Jason is particularly adept at building customer-focused teams that work cross-functionally and cross-culturally, fostering collaboration that drives innovation and enhances operational efficiency. His strategic development initiatives have proven instrumental in improving existing processes while simultaneously launching new products, ensuring that organizations not only meet but exceed industry standards. With a deep understanding of Good Manufacturing Practices (GMP), design control, and verification and validation (V&V), Jason Bilobram is committed to empowering clients in the Life Science and Biotechnology sectors to achieve sustainable success in an ever-evolving regulatory environment.
