Responsible for a portfolio of over 500 applications, a global organization of over 150 seated in 15 countries, an annual budget in excess of $100MM, and delivering millions of dollars of business value. Highlights include:Full Lifecycle accountability for global LIMS, MES, QMS, Doc Mgmt, LMS, CMMS, Serialization and analytics solutionsCompletion of board level corporate integration targets within 9 monthsProcess and data standardization driving digital readiness In addition I had governance responsibility for Data Integrity, Combination Products, General Data Protection Regulation and Digital Plant of the Future design.

In this role, I provide client partner and solutions management for the global quality operations organization. My team of Business Technology specialists provides solutions for laboratories, quality management, training, product complaints and document management.

Responsible for all technology for the wholly owned subsidiary with multiple locations in St. Louis and Columbia, MD.

Developed and managed the technology process framework, governance and risk management practices.

Responsibility for computer program teams in support of various Quality Systems including Deviations, CAPA, Change Control, Document Management, LIMS, CDAS, DA and Integration; team lead of Quality Operations at Corporate location.Special Assignments: Consent Decree remediation; European Change Control and Regulatory Label Artwork; Warning Letter response Puerto Rico, 3rd Party Verification of Computer Systems procedural controls.

Led key compliance and efficiency efforts including ISO 9002 Certification and various Kaizen efforts in Production/Operations.

Responsible for all quality functions of a prime label manufacturer supporting the pharmaceutical, medical device, food and cosmetic industries. Initiated formal quality measurement systems, implemented standard operating procedures, developed and implemented supplier audit programs.

Six months of training in quality and systems development in Japan, 3 years as corporate supplier auditor for Pacific Rim suppliers, Quality Assurance Engineer, Manager Customer Service, Product Development and Quality Assurance