Michael Reilly Email & Phone Number

Union, Nj

Manages Computer System Validation Teams, Services, and Metrics within the Pharmaceutical industry. Currently over a $13M revenue stream. Partnered with the Patel sales team to understand client’s needs and develop appropriate portfolio/staffing/project solutions.

Cape May, New Jersey, United States

Pharmaceutical Computer Systems Validation and Quality - Software Database Design - Hardware Engineering - Inventory systems

Rahway, Nj

Lead Senior Analyst for Global Regulatory Submissions. Worked with the Business and Technical Units to implement several software and functionality upgrades to Merck’s Regulatory Publishing System. Developed the Validation approaches incorporating CSV SOPs for two new large scale system implementations that were brought on-line, a global application portal and a combined multiple system business solution. Authored complete sets of documentation for all phases the above systems including Requirements, Validation Plans, Summary Reports, Design and Development Testing, and User Acceptance Testing. Provided compliance and regulatory guidance.

Kenilworth, Nj

SPRI Validation Lead – 2009 through 2011 – Analyst for the data migration of Schering-Plough document publishing systems. Developed the System Validation Test Strategy Plan approach to validating the system utilizing ANSI standard sampling techniques to create the test plan for thousands of transformed and migrated records. Contributed to and reviewed all project documentation. Programmed a test script data worksheet database application with Microsoft Access that generated several hundred Excel worksheets for the data migration record testing phase of the validation effort. Wrote the Validation Summary Report when the testing was successfully completed. Performed Periodic Reviews of Regulatory Systems and revised documentation as required. SPRI 21 CFR Part 11 Program Project Manager 2004 through 2008 – Project Manager for the SP Research Labs Part 11 program. Provided Validation guidance and Remediation process direction . Managed metrics, progress reporting, authored several strategy documents, and conducted document reviews. Hosted program audits and directed audit findings response efforts. Authored and provided presentations and training for personnel involved in the program. Contributing core member for several corporate Policy and Process development efforts such as the Risk Assessment Team and the Part 11 Interpretation Team. SPRI 21 CFR Part 11 Program Assessor - 2002 through 2003 - Conducted Part 11 gap analysis for hundreds of systems covering applications, clinical databases, lab Instruments, and document control systems. Each assessment included an interview that produced a summary report indicating system gaps and recommended remediation solutions.

Technical lead for design and development of an integrated pharmaceutical document management and publishing system used by Regulatory Affairs for electronic NDA submissions to the FDA. Wrote the System Design Specification, the Installation Qualification (IQ) protocols for servers, workstations, networking, and client applications. Created the test data set and worked as part of the validation team to produce OQ and PQ protocols.

Education record

Education record