Career Summary
20+ years of validation / compliance / remediation experience
Work Experience
- Vice President - Business Development & Operations
- Validation Plus Inc. (1 ~ 49)
- January 2010 - Present (2 years 1 month(s))
- - leading initiative to engage pharma & biotechs China-wide regarding compliance & validation to FDA & EMEA standards
- China - based in both Beijing --&-- Shanghai
- computer systems validation / compliance principal
- andesys (1 ~ 49)
- January 1993 - January 2010 (17 years)
- 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":
* WUXI Pharmatech - [in Shanghai China onsite]
* Yokagawa - [in Singapore vendor audit onsite]
* Amgen -
... [Regulatory CSV Corporate-Audit-Preparedness Program]
... [Prevention of: FDA "Warning Letter" & "Consent Decree"]
* Genentech -
... [CSV Mgmt Audit - Prevention/mitigation of FDA sanctions]
* Allergan -
... [FDA "Warning Letter" Remediation: CSV]
* Glaxo-Smith-Kline - [CSV for new $120 million facility]
* Cephalon - BioTech [Pharmacovigilance]
* American Red Cross - Quintiles Transnational
... [FDA "Consent Decree" Remediation: CSV]
* Pharmacia - Monsanto - [SAP CSV]
* Johnson & Johnson - Cordis -
... [FDA "Warning Letter" Remediation: CSV of 1000s LIMs]
* Pfizer [CSV: Building Mgmt & Security]
* BioValidation
* Chiron [Pharmacovigilance]
* Aradigm BioTech
* Visible Genetics - [DNA sequencing medical device]
* Royal Bank [Dominion Securities] [NYSE top 15]
... [compliance for 1400+ systems]
* Bank of Montreal [Treasury & Corp-Banking] [NYSE top 25]
... [compliance for 1100+ systems, savings > $15 million]
* Nesbitt-Burns
* Harris Bank
* confidential Bank & Investment-Bank
* GAP - [PMO SOX Compliance]
* LookSmart & SOX Compliance
* JAN Mkt'g - [successfully defended audit findings]
* Raytheon [Hughes Aircraft]
* AT&T - NCR
* Interactive Media [IVR]
* ActFit
* Ontario Lottery
* Nortel - Architel
- IT-QA compliance officer adjutant
- The Bank of Montreal Group of Companies [Nesbitt-Burns, Harris Bank, etc.] (Over 5000)
- January 1997 - January 2000 (3 years)
- a NYSE 25th largest Bank's Treasury --&-- Corporate Banking divisions'
Compliance IT-QA
[ reported to Compliance Officer who reported to Sr.-Exec.-VP.]
--- in role #1 ---
Designed SEC compliance strategy PMO-enterprise-wide for $31+B
Bank's Treasury division --&=- Corporate Banking division that:
[ + included Nesbitt-Burns brokerage, Harris Bank Chicago, & 32
int'l Trading Floors] --my FDA pharma-esque CMMI level 4 model
saved >$ 13 Million & --was #2 to Compliance Officer & sign-off
Headed Compliance Audit & guidance for 1100+ systems' [s/w, o/s
d/b] validation procedures for all global Treasury -& Corporate
Banking -& all Nesbitt-Burns brokerage [ $150 Million project ]
Ensured 4 bank 'divisions' met enterprise-wide SEC compliance
goals while aligning requisites as PMO --&-- signed compliance
due diligence thus directed 1000+ projects', 1000s of analysts'
compliance integrity & deliverables; triage contingency plans
--- in role #2 ---
Matrix-managed 5 "Value-at-Risk Senior Proj-Mgrs", & 60+ staff;
ensured compliance standards & schedule responsibilities met
Education
- University of Toronto
- Electrical Engineering Bachelor's
- 2010 year - 2015 year
- Ottawa University
- French Language Immersion Other
- 2010 year - 2015 year
- University of Toronto
- Semi-Conductor Electronics - Master's courses Other
- 2010 year - 2015 year
- University of British Columbia
- French Language Immersion Other
- 2010 year - 2015 year
Other
- Skills : validation, compliance, remediation, I/T-Q/A, IT-governance
- Industry:Consulting