Van Benson Email & Phone Number

New York City Metropolitan Area

Managing business, regulatory and quality activities from R&D through post-approval for Drug/Device, ANDA and NDA products.

Managing compliance improvements for Medical Device, Food Contact Materials and Pharmaceutical Ingredients+ASQ Certified Quality Auditor managing cGMP and ISO13485 conformance.+Sales/Marketing collaborations for customer value propositions and relations management+Six Sigma Certified for leading process improvements, Continuous Improvement and Operational.

GMP QMS program management for ANDA submissions/filings and deficiency responses+Managed a QC, QA and RA team of 10 employees +Managed FDA and DEA interactions & communications +Achieved Consent Decree Removal, passed FDA inspection and gained 6 ANDA approvals

Regulatory and Quality advisor for extensive product and facility compliance improvements +Managed QC and QA team of 30 employees to improve QMS compliance with GMPs +Installed/qualified instruments and equipment, created/validated test methods and improved SOPs+Achieved Warning Letter closeout 1 month ahead of 12-month schedule

Improvement and Expansion of Technical Services Division +Expanded technical documentation and added ISO/GMP QMS and program improvements +Created new marketing materials, networked and gave regulatory compliance presentations+Expanded service portfolio and achieved Operational Excellence to gain major new customer contracts

IND and NDA support for submission documentation including test methods, protocols, qualifications, validations, product development reports and SOPs.

Pilot Plant CMC team member - Analytical R&D with focus on QbD implementation and documentation for Chemistry, Manufacturing and Controls (CMC); Major collaborations with IT on IQ/OQ/PQ projects for new instruments and technologies; Member of Continuous Improvement Committee & Global Specifications Committee.