Responsible for the management of quality and training departments for the Pharmacovigilance and Medical Communications business units.

Oversee and optimize Quality Assurance operations and personnel at two sites; included responsibility for Quality Assurance laboratory oversight, budgeting, enterprise-level project support, annual product reviews, validation activities, batch records, CAPA, OOS, deviations, training, market release decisions, and facility renovations.• Reduced the cycle time of a previously-manual change control system 57% (28 to 13 days) by leading the implementation and validation of an automated workflow utilizing the Livelink EDMS.• Increased training efficiency by identifying, implementing, and validating a Learning Management System (EduNeering ComplianceWire) that facilitated training delivery, assessment, and reporting across sites.• Reduced training time (one day to 30 minutes) and optimized reporting process (4 minutes to 3 mouse clicks) by implementing a web-based customer complaint program to replace a legacy DOS system.

• Ensured quality operations through management of QA personnel and oversight of cGMP, CAPA, internal auditing, product release, and other quality programs.• Managed site relationships with regulatory bodies and auditors from the USDA, FDA, FAA, and ISO.• Created and managed a yearly QA budget, meeting all quarterly performance indicators.• Created and implemented a process for efficiently handling annual renewal of wholesale licenses for all 50 states.• Led the 21 CFR Part 11 validation of the Warehouse Management software system.