Providing QA and Manufacturing services to the Pharmaceutical and Biopharmaceutical industries. Key services include selection and qualification of contract manufacturing organizations (CMOs) and contract research organizations (CROs), Quality System design and SOP implementation, GXP auditing and follow up, internal GXP assessments, pre-approval inspection preparation, detailed document review (Protocols, Reports, Batch records, etc.), interim leadership.Recent projects include:• Assessment of Compounding Pharmacy practices for compliance with FDA Guidance documents & USP• Team lead for third party Batch Record review activity as mandated by Consent Decree• Team Lead for cGMP auditing of Consent Decree required remediation activities at multi-site company • Established Quality System and led the development of a comprehensive set of Quality Standards for a multi-site company• Wrote first Quality Manual and Quality Policy, and established the development of selected SOPs for multi-site company utilizing cross functional teams• Developed and delivered training program for preparing for and managing FDA inspections

Responsible for Clinical and Commercial QA activities worldwide