Gerald Sawicki

@ Novartis Pharma Basel Headquarters Project Quality Mgmt– Global TechOps.QA.IT • key global impact enterprise-wide program: Change Control Excellence • Oracle Agile PLM "Product Lifecycle Mgmt": all changes • from: manufacture raw material drug substance –> formula finished product • for: all 10,000 SKUs data (current–compliant–consistent) • to: ~140 countries' Health Authority Regulations market authorizations/exports • IT Quality Mgmt CSV Computer System Validation expertise & Info. Governance

• one of the sub - projects / clients under HGP AG –– Halfmann Goetsch Partner AG • one of the sub - projects / clients under IBM –– I/T SOX Business Compliance Controls

Aligned strategic programs/organization & management of PTG IT CoE Europe spanning scope: • CoE = Center of Excellence –– regarding project delivery teams • re: Private-Banking & Wealth-Management & Investment-Banking software needs, i.e.: –– Equities, Prime, Fixed Income, FX product lines & horizontal –– IT business clients/stakeholders –– re: software sign-off before delivery to production.

Conducted audit/assessments re: IBM's major int'l Pharma – SarbanesOxley & GxP Compliance Controls globally Audited SOx-404 Compliance Controls worldwide – control, mitigate risk, remediation – internal assessments

Led initiative to engage pharma & biotechs China-wide regarding compliance & validation to FDA & EMEA standards China – wide: –––– BeiJing based –&– –––– ShangHai based –&– –––– [ SuZhou / HangZhou / NanJing / ShiJiaZhuang / TianJin / ShenZhen / XiNing QingHai ]

Engaged Internet start-ups to mature int'l biotech-pharmas & bank-brokerages in diverse roles: QA Director, Validation Project Mgmt, QA Architect / auditor Projects "CSV"="Computer Systems Validation": • Pharmaceutical & Medical Device & BioTech companies (including: GxP) • Banking & Brokerages & Financial Companies (including: SOX / compliance) • High-Tech Company roles • spanning: Americas / Asia / Europe

[ Iconix Int’l Div. ] Managed teams to ensure UNIX RTOS "Real-Time-Operating-System" QNX client/server design was successful thru all stages: marketing-intent inception––>retirement; streamlined QA - system integrity; introduced TQM Operating System was designed to: • "dual–standalone/networked" = function self-contained –or– using network resources • "dual–boot" = boot from QNX –or– boot Novell –or– boot Windows • "dual–network" = use QNX-network info packets –or– use Novell-network info packets

• Thesis: "Photovoltaic Conversion of Solar Energy to Electrical Energy" . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • semi-conductor physics / electronics graduate courses . . . . . . . . . . . . . . . . . . . . . . • bio-medical & systems

French Language Immersion

French Language Immersion