Quality control and regulatory consultant

NaturMed IVL

• Managed quality department for dietary supplement manufacturer

PCT

• Directed all aspects of Quality Assurance/Quality Control in the Mountain View PCT site for the cellular therapy industry. Was interim VP of Quality for 3 months for both Mountain View and the Allendale New Jersey facilities

• Managed quality assurance and quality control teams

• Ensured facility quality compliance was in accordance to corporate procedures and applicable regulations

Becton Dickinson

• Director of regulatory

• Directed the regulatory affairs activities such as interactions between BDB and agents of the US FDA and health ministries outside of the US. Contributed to the development of strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Provided functional excellence in regulatory activities to achieve rapid worldwide clearance/ approval/registration/licensure of BDB products with desired claims