QUALIFICATIONS SUMMARY
Manager with unique combination of technical and interpersonal skills. Managed and executed every aspect of the system development lifecycle including documentation development, application configuration, validation and deployment of multiple GxP computer systems, applications, and third-party hosted solutions. Maintained ongoing compliance with 21 CFR Part 11 and Sarbanes Oxley Regulation (SOX).
Specialties
• Relationship building
• Coaching and developing others
• Written presentation
• Negotiation
• Mentoring
• International business (Asia Pacific)
• Maintained ongoing compliance with
- 21 CFR Part 11
- COBIT
- Sarbanes Oxley Regulation (SOX)
• Validated eDMS and SAP
Sunovion, Fort Lee, NJ Jan 2009 - Aug 2011
Wholly-owned division of Dainippon Sumitomo Pharma (DSP). DSP is multi-billion dollar, top 10, Japanese pharmaceutical company with a diverse portfolio in research, animal health, food science, and specialty products.
IT Compliance Manager / Validation Lead
• Provided compliance guidance to ensure that all GxP applications were validated and deployed in accordance with 21 CFR Part 11 requirements.
• Conducted site wide GAMP 5 training on risk based approach to validation
• Monitored the overall compliance health of the IT organization, conducted assessments, introduced and drove best practices
• Assisted IT Director in Start-up environment: responsible for the development and implementation of computer validation program in support of new company
• Conducted supplier audits and assessments. Evaluated proposed software and services. Provided direction and recommendations during IQ, OQ, and PQ test execution
• Authored Site Disaster Recovery and IT Procurement Procedures
• Managed global change management process. Assessed and approved all proposed IT Changes
• Managed virtual testing teams consisting of employees and consultants, from the UK, Japan, and US during global implementations of the Adverse Event Reporting System (AERS) and Electronic Document Management System (EDMS)
Schering Plough, Kenilworth, NJ 2004 – 2008
a $12 billon dollar, global, research-based pharmaceutical company.
Validation Lead
• Managed, developed, and coached staff of 8 system administrators responsible for the 24 x 7 support and change management of over 200 validated GxP applications and systems.
• Reviewed test scripts and supporting documentation to ensure all testing requirements were met
• Mapped process, identified gaps, overcame cultural differences, and language barriers to implement aligned process across 6 Asia Pacific countries
• Coordinated Infrastructure, Server, Vmware, and local Network qualifications
Pfizer Inc., Morris Plains, NJ 2002 - 2004
The world's largest research-based pharmaceutical company
Manager, Information Technology (IT) Compliance.
Led compliance team responsible for enforcement of IT qualification strategy across the Americas ensuring compliance with all corporate policies, procedures, and industry standards.
• Documented network qualification in response to FDA observation
• Mana...
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