P.E.B. Commodities, Inc. is a domestic & international service company specializing in expert consultation & forensics services involving frozen, fresh & prepared foods¸ pharmaceuticals, grains, wine, beverages & other perishables. Leads & conducts investigations by collaboration with all players & experts to establish probably cause & origin.Engagements include interactions with clients, experts & stakeholders representing domestic & multinational companies, insurance underwriters, P&I Clubs, private entities, & local, national & international purveyors of pharmaceuticals, beverages, wines & horticultural products.Assignments in-progress include claims investigations, probable cause and origin of claimed losses, expert services involving claims and litigation, fact & science based assessments, expert reports, quality assurance, clinical quality, standard operating procedures, regulatory affairs/agency regulations, compliance with applicable regulations, licensing & inspections, labeling, product integrity, corrective & preventive action (CAPA) investigations, risk assessments & validation as well as processing, manufacturing, warehousing, inventory management, transportation & logistics.

Oversight of GMP compliance of specified products in development within the antibody & cellular therapy arena; included the development, implementation and management of quality metrics/ reports and alignment with process & product validation programs.Developed a quality management system appropriate for clinical material while working towards commercialization with a focus on the Quality Manual, policies & quality systems such as deviation/ Corrective/ Preventive Action (CAPA), change control, quality risk management & management review.Supported a quality management system appropriate for the activities of our Contract Management Organizations (CMO) involved in the manufacture & test of T-Cell cellular therapy programs. Organized/ oversaw CMO execution of investigations & assured completed & accurate documentation. Liaised for CMO change management & led the development & implementation of master batch record & client-specific procedures for clinical labeling/ packaging of clinical material for distribution to sites. Managed continuous quality improvement initiatives.Worked collaboratively with both internal and external client/ collaborators and with regulatory agencies to anticipate & resolve quality issues.

Head of the Artwork Management & Change Control Operations (CCO) which supported artwork development for labeling & packaging materials for all Shire products globally, including those within the CMO network as well as within internal manufacturing operations. Managed personnel in artwork centers including Dublin, Ireland with graphic design studios residing in Lessines, Belgium, Vienna, Austria & Westlake Village, CA USA.The organization drove material changes via Change Control across internal manufacturing operations, taking into account supply planning/ forecasting, product launch timelines & other critical variables to strategically manage materials & to ensure supply continuity.Process Owner of the artwork/ labeling change process tasked with the integration a new combined, global process post-merger; champion of continuous improvement efforts leading to best-in-class process simplification with reduced cycle times & costs with gained efficiencies.(Baxalta acquired by Shire)

Led Global Labeling organization across all three (3) labeling centers located in Lessines, Belgium, Vienna, Austria & Westlake Village, CA USA, supporting all products and labeling/packaging operations. Harmonized & standardized a new global labeling change process.Quality lead for labeling design/development and labeling operations, including re-branding efforts with the spin-off of Baxalta from Baxter. Led the effort by by establishing an expedited process for changes with a Quality Project Plan (QPP) & establishing an outsourcing partner for artwork development. Sought, obtained & managed $5MM budget for outsourced artwork development for the re-branding effort. With the support of other key business functions, the result was no product continuity issue or supply interruption during the transition.Champion and lead for Product Integrity Program Office.(Baxalta formerly Baxter)

Led Global Labeling across all three (3) labeling centers located in Lessines, Belgium, Vienna, Austria & Westlake Village, CA USA, supporting all BioScience products and labeling/packaging operations as the BioScience Division Quality lead for labeling design/development & artwork operations.Champion for Product Integrity Program Office, led risk assessments & implementation of authentication & security features to packaging materials for products distributed worldwide; maintained budget for the mandated initiative.Held additional responsibilities within several quality systems including CAPA, non-conformance investigations, training & due diligence & integration with additional support of agcency inspections globally.

Product Integrity (Anti-Counterfeiting) Program champion for BioScience products. Established the Product Integrity Program Office and lead and support of initiatives and implementation in the areas of product authentication, tamper evidence, and track & trace. Presenter at international industry conferences regarding Product Integrity risks & mitigation efforts.BioScience Division Quality lead on labeling design/development and artwork operations. Led the labeling center located in Westlake Village, CA USA, which supported various products at four (4) different manufacturing facilities.

Developed and deployed quality systems, focusing in the areas of clincal, training, labeling, and product authentication/anit-counterfeiting. Lead multiple CAPA investigations utilizing DMAIC tools. Executed due diligence and post acquisition project plans for the successful integration of the Quality Management System.Team member for corporate level initiatives and continuous improvement projects.Assist in facility level improvement and investigative activities.

Owned the change control quality system for critical systems. Also, provided oversight and approvals non-conformity investigations for utilities and other processes.

Performance Qualifications involving room qualification of cleanrooms as well as utilities such as Water-for-Injection (WFI), Reverse Osmosis (RO), and Compressed Gases. Additional work on facility and HVAC design reviews.