• Talent management, coaching and goal setting for department of ~35 quality personnel with 6 direct reports including 3 frontline leaders.• Collaborates with a cross functional team to ensure compliance procedures to design controls and fulfillment of user needs. • Implement quality systems that are in compliance with quality assurance standards that track and trend performance metrics. • Maintain the compliance standards in accordance with the GCP, GLP, 503B Guidance while mass producing injectables and dermatological products. • Manage 503A and 503B Operations and apply compliance standards outlined in GCPs, GLP, GMPs, and 503B Guidelines.• Facilitate internal and external audits with regulatory, state, vendor/suppliers and laboratories such as GCP, GLP, FDA, Texas, DEA, and other regulatory agencies. • Liaison that conducts the audit, manages audit responses, and fulfills document request to auditor. • Oversees the Supplier Vendor Qualification program which entails (supplier/vendor audits, vendor qualification document review and prepares/approves Quality Agreements. • Generates Standard Operating Procedures (SOPs) that provide general guidance for standards such as 503B Outsourcing Facility, Code of Federal Regulations Title 21 and FDA Guidelines. • Develops mitigation plans that alleviate risk within the process to mitigate non-conformance incidents. • Implemented an Electronic Quality Management System (EQMS) – Compliance Quest replacing an historical paper-based QMS system. • Performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for implementation of EQMS. • Created focused team to complete open Investigations, Non-Conformances, Deviations, and Customer Complaints. • Managed Non-Conformance mass closure initiative to reduce open investigations by 70% in a six-month time frame.

Extensive experience in global quality systems design and implementation, quality assurance and compliance in the pharmaceutical and medical diagnostics industries. Specialties include supplier quality, product complaint management, quality standards, change management, investigations, document management, quality metrics, and quality risk management. Demonstrated ability to direct multi-disciplinary projects and promote collaboration to achieve organizational goals.