James ***** is a highly experienced QA/Compliance executive who has demonstrated the ability to lead diverse team of professional to new level of success in highly competitive life science industry. Strong leadership and technical qualifications with impressive track record of more than 16 years of hands-on experience in quality system and regulatory compliance management, regulated document control, GCP/GMP/GLP compliance audit, implementation of technology solutions to business. Proven ability to successfully analyze organization’s critical business requirements, identify deficiencies and potential opportunities, and develop innovative and cost effective solutions for enhancing competitiveness, increasing revenues and achieving business goals. Success has been acknowledged throughout the excellent services to major pharmaceutical companies such as ***** Clinical ***** , Eli Lilly, Johnson & Johnson, Abbott Lab, Novartis, Purdue Pharma, Dupont Pharm, MDS Pharma Services etc.
Customer Oriented, Global Leadership, Consensus Builder, IT Solution to Business, Quality, Validation, Compliance, GCP/GMP/GLP, Clinical Research, Auditing, Process Improvement, Outsourcing and Vendor Management, Disaster Recovery and Business Continuity
CAREER HISTORY AND HIGHLIGHTS
Feb 2004 to Oct 2009
DIRECTOR, Quality Assurance & Regulatory Compliance, ***** Clinical ***** Inc.
James ***** joined ***** Clinical Technology at the critical moment when the company was losing money and revenue was declining because of the lack of high performance quality and compliance team and programs. The client satisfaction was at the lowest level with a series negative audit reports to respond to. James worked with executive team to develop the consensus to brand the ***** Clinical Technology as a pharmaceutical service provider with quality and compliance as core value. Subsequently, he built up high performance QA team, initiated and implemented several key QA and compliance programs leveraging state of the arts ***** . As a result, the company completely reversed the negative client perception, become profitable again and had achieved 30% revenue growth in the last 4 consecutive years.
June 2000 to Feb 2004
SENIOR CONSULTANT, CimQuest Inc. , Eli Lilly and Company
As a recognized industry thought leader and frequent public speaker, James ***** accomplished various challenging management consulting services with fortune 500 companies such as, Eli Lilly, Johnson & Johnson, Abbott Lab, Novartis, Purdue Pharma, Dupont Pharm, etc. His innovative and result oriented approach in solving business problem has saved these companies millions of dollars and remediated significant quality and compliance risk leading to subsequent business growth. These projects includes: 1). IT Infrastructure planning, implementation and qualification with first class disaster recovery and business continuity capacities, 2). Drug manufacturing facility commissioning, qualification and validation with sophisticated DeltaV DCS Control system, 3). Development, implementation and user training of global Corrective and Preventive Action (CAPA) program to improve compliance and eventually led to the remediation of FDA consent decree and rapid business growth again, 4). Implementation and validation of global ERP systems, MES system and e-Clinical Solutions to significantly improve the operational efficiency, product quality and profit margin by 30%
June 1994 to May 2000
DIRECTOR, Global IT Infrastructure Validation and Compliance, MDS Pharma Services Inc.
James ***** joined MDS Pharma services as a senior analyst and enjoyed fast track promotion through a series of increasingly responsible senior management positions to meet challenges of fast business growth, technology expansion and process improvement. James ***** effectively built and led a team to establish the strategic IT infrastructure vision, identified key IT application solutions. By implementing a 3 years step by step roadmap, James led the team to successfully deploy an Enterprise Resource Planning (ERP/SAP) system, LIMS System and Oracle Clinical System, Document Management System to global operations, which enables the company to conduct business with significant technology advantages and improved profit margin by 35 %. James ***** held a several key positions and committee chairs during his tenure in MDS Pharma Services. He was recognized as result oriented, innovative, highly motivated and effective leader, problem solver and hands-on solution provider
EDUCATIONS AND PROFESSIONAL TRAININGS
James ***** earned his Ph. D from McGill University in the field of computer control and automation in engineering design. He is member and frequent speaker of Drug Information Association and Parenteral Drug Association conference. James participated in various professional training programs and obtained certifications in: 1). Manufacturing Planning & Execution for Discrete & Repetitive, 2). Supply-Chain Management System, 3). ERP/SAP solution and implementation strategy, 4). Leadership training: Peak Performance, 5). 21 CFR Part 11, 210, 211, 820, ISO ***** , 510K, ICH
J and P Technology Compliance
***** Clinical Technologie
Ph.D, McGill University, Engineering automation with computer control
4 years of consulting services with CimQuest Inc. Consulting services and worked with most major fortune 500 pharma companies