New Execs at USDM Life Sciences Focus on Quality and UDI

USDM Life Sciences has hired two new executives. Enterprise Quality Management Practice Director Brian McCole has a 20 year IT implementation track record, according to the Santa Barbara, Calif., company. His experience includes 15 years of developing and supporting quality management system (QMS) programs and 10 years of managing enterprise resource planning (ERP) system programs. He also has experience with business process improvement, regulatory compliance and the governance supporting  life sciences technologies.

Most recently, McCole was a director of quality/CAPA (corrective and preventative action) systems and compliance, creating a global quality system for one of the world’s largest bio-pharmaceutical manufacturers.

McCole will leverage his quality management systems experience to help USDM Life Sciences clients enhance their QMS, achieving their quality objectives and maintaining regulatory compliance. McCole has experience with many QMS and ERP vendors, including ETQ, Master Control, Oracle, Pilgrim, SAP and TrackWise, USDM executives claim.

“I look forward to working together with our clients to stimulate continuous quality management improvements and business benefits through the deployment of operational excellence,” said McCole.

“Brian’s thought leadership, hands-on knowledge and experience with QMS systems and regulations augments our existing staff and provides an unparalleled blend of expertise to USDM’s capabilities,” said Robert Lesnefsky, USDM’s global vice president of quality assurance and regulatory compliance and auditing.

USDM also has hired Grant Hodgkins as vice president of the company’s Commercial Practice.

In his new role, Hodgkins will help the company’s clients with pharmaceutical track and trace, ERP, product information management, product life cycle management (PLM), manufacturing execution systems and other commercial enterprise solutions. Hodgkins will partner with Jay Crowley, vice president of USDM’s unique device identification (UDI) practice to help clients achieve UDI compliance.

Hodgkins has 29 years of experience as a leader in global supply chain, master data management, software quality assurance and project management. He specializes in developing enterprise-wide business strategies and Lean improvements. His experience includes pharmaceutical track and trace, UDI, product traceability, barcoding, radio frequency identification, PLM, ERP and computer system validation. He most recently headed global data management at Alcon Laboratories Inc., a Novartis company.

“I am very excited to join the thought leaders at USDM Life Sciences. I am confident the team is well-positioned to build success across all service and solution areas for our life science clients,” said Hodgkins.

“Grant is joining USDM at a critical time of change in the life science industry. Life science organizations are quickly trying to adapt to new government regulations and develop more cost effective business strategies. His experience will give our clients incomparable guidance with the new regulations and more profitable business methods,” said Kevin Brown, managing partner at USDM.

Hodgkins recently served as tri-chair of the GS1 Healthcare Leadership Team, co-chair of the GS1 Healthcare AIDC Application Standards Work Team and co-chair of the GS1 Healthcare GDSN Implementation Work Team. Hodgkins is a PMP-certified project manager.

USDM Life Sciences is a global regulatory consulting firm that provides compliance, validation, qualification, quality, auditing and information technology services via project teams and staff augmentation to medical device, biotechnology, biologics, diagnostics and pharmaceutical clients.