Head of Quality & Compliance for a specialty pharmaceutical repackager and relabeler. Responsible for all aspects of Quality & Compliance including Quality Assurance, Supplier Quality Management, Quality Systems, as well as Corporate, Regulatory, and EH&S Compliance.

Responsible for Quality Assurance oversight for Plasma Fractionation, Purification and Filling operations at Shire's Los Angeles Plasma Fractionation Facility operations. Member of Site Leadership Team responsible for setting strategic direction and operational activities for the Los Angeles Site.

Responsible for Quality Assurance oversight for Plasma Fractionation at Baxalta's Los Angeles Plasma Fractionation Facility including exception management, product quality decisions, product release, quality operations and regulatory compliance.

Responsible for Quality Assurance oversight for Plasma Fractionation operations at Baxter's Los Angeles Plasma Fractionation Facility, including exception management, product quality decisions, product release, quality operations and regulatory compliance.

Developed and implemented an enterprise risk management program to effectively identify, characterize and manage Amgen's strategic risks. Implemented a company-wide risk management methodology, including a risk rating tool and risk assessment process. Established a reporting process to inform the CEO executive team and the Board of Directors of the company's top risks.

Developed, implemented and maintained Amgen's Quality Management System in alignment with ISO 9001 and ICHQ10. Responsible for quality system process performance and reporting to executive management.

Responsible for all aspects for Quality Assurance for small molecule and protein manufacturing facilities for both commercial and investigational products. Lead regulatory and partner inspections for commercial pharmaceuticals and biologics manufacturing, testing and distribution facilities.

Provided quality assurance oversight for clinical, commercial, and cell banking operations.