Brien Fox Email & Phone Number

Greater Los Angeles Area

Greater Los Angeles Area

Greater Los Angeles Area

Los Angeles, Ca

- Responsible for approving investigation occurring in Aseptic Filling and Packaging.- Assures conformance to regulations, participates in quality assessments, and manages continuous improvement projects- Support FDA and other agency audits (China, EU, and Internal) – Interact directly with agency, completing audit requests, and devising strategies for responses.- Support multiple projects in the Pharma Business and across multiple Baxalta sites- Supported development, validation, and regulatory fillings for lyophization, filling equipment, capper, autoclave cycles.- Contribute regularly to regulatory filings and responses- Coach multiple groups (production, engineering, investigations, and validations) on being Audit ready.

Sr Manager Manufacturing, Events and Process ImprovementsSeptember 2012 to May 2013Sr Manager Manufacturing, Aseptic Filling and Lyo:July 2011 to September 2012Manager Manufacturing, Compounding and Hydration; February 2010 to July 2011Associate Manager Quality Assurance; May 2007- January 2010 Quality Assurance Specialist, QA Compliance; August 2006 - May 2007Quality Assurance Specialist, QA Outsource Manufacturing Group; April 2005-August 2006

Pacific Regional Laboratory Irivine, California

Responsible for analyzing drug samples, reviewing test methods for new drug applications and conducting due diligence and for cause inspections of a variety of different types of regulated industries. Solely responsible for developing, installing and maintaining laboratory-wide purified water system for new FDA facility. Experienced in creating systems and developing procedures to achieve ISO-certification (ISO 17025).

Quality Assurance Associate II, Corrective and Preventive Action group (CAPA); January 2000 - August 2001Responsible for leading, reviewing and approving investigations. Also responsible for verifying corrective actions for: SOP departures, deviations from master formulas, manufacturing equipment issues and out-of-specification laboratory results. Winner of multiple awards for reviewing and validating new corporate exception database used by R&D and Manufacturing. Laboratory Technician III; October 1998 - January 2000Responsible for testing systems for drug delivery amounts and impurities in GLP laboratory. Responsible for developing and revising SOPs and test methods. Initiated lab automation projects resulting in $90,000 annual savings and reduced cycle time from 12 days to 36 hours.