New Execs at USDM Life Sciences Focus on Quality and UDI
USDM Life Sciences has hired two new executives. Enterprise Qual- ity 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 Track-Wise, 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 manage-
ment (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
“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 regula-
tory consulting firm that provides compli-
ance, validation, qualification, quality, au-
diting and information technology services
via project teams and staff augmentation
to medical device, biotechnology, biolog-
ics, diagnostics and pharmaceutical clients.
Noxilizer Appoints Director of
Customer and Technical Service
Noxilizer Inc. has hired Robert Contino
as director of U.S. customer and techni-
cal service. Contino will be responsible
for developing, building and directing the
company’s customer service delivery pro-
gram in the United States, with a focus on
implementing efficient processes and de-
livering on customer expectations.
“Noxilizer is committed to provid-
ing experienced, responsive personnel to
meet the needs of our customers,” Presi-
dent and CEO Lawrence Bruder said.
“Strong customer relationships, like those
Bob is known for cultivating, build loyalty
that will help us successfully grow our
business in the long term.”
Contino brings more than 20 years of
hands-on experience in industrial and
healthcare sterilization, including building
and managing technical support teams.
Prior to joining Noxilizer, he served as
senior regional service and business man-
ager at Irvine, Calif.-based Advanced Ster-
ilization Products, a Johnson & Johnson
company. Contino’s service team was the
top-performing group in eight of the last
12 years and led the industry in customer
satisfaction, according to Noxilizer.
“Noxilizer prides itself in partnering
with customers—beginning with devel-
oping custom solutions with an NO2 tech-
nology that sets itself apart from the tradi-
tional methods. I look forward to building
a team that exceeds customer expectations
with rapid response and above industry
service ratings,” Contino said.
Contino will be based at Noxilizer’s
headquarters in Baltimore, Md.
Noxilizer provides room temperature
nitrogen dioxide sterilization technology,
sells sterilization and decontamination
equipment, and offers contract steriliza-