SHAUN H. WILLIAMS
*** ********** *****, ****, ** 27513
919-***-**** • **************@*****.***
http://www.linkedin.com/in/shaunwilliams
PROFESSIONAL SUMMARY
Highly accomplished operations professional with more than 15 years of experience directing a
broad spectrum of operational activities in medical products and software segments. Analytical,
results-oriented leader with track record of leveraging Lean, Six Sigma, Theory of Constraints,
and Total Quality Management principles to drive productivity. Excellent communicator and
innovative problem solver. Critical change agent adept at fostering organizational change to
achieve compliance with industry standards and regulations, including Title 21 CFR Parts
210/211, 6xx, 820, and 11.
Strategic & Business Planning • Regulatory Compliance • Financial Management • Project Management • Client
Relations
P&L • Sales & Operations Training Programs • Supply Chain Management • Business Forecasting • Mentoring
Customer & Partner Development • Team Building & Leadership • Cost-Savings Initiatives
PROFESSIONAL EXPERIENCE
INDEPENDENT CONSULTANT, Raleigh, NC • 2012-Present
Contract work utilizing my years of experience in operations to help companies improve their
business performance.
Key Achievements:
• Assessed the current state of a DOD design/manufacture firm’s (Avalex Technologies, Inc.)
operational departments, identified gaps between this current state and the desired level of
performance, and created a plan to address those gaps. Project completed under budget and on
time.
• Assisting in a startup company building their sales pipeline via web-based research and sales
operations planning.
HEALTH DECISIONS, INC., Durham, North Carolina • 2011-2012
Full-Service Contract Research Organization (CRO)
Vice President of Operations
Led all operational departments, including Biometrics (Biostatistics,) Clinical Affairs, Data
Management and Quality Management, for this innovative CRO. Responsible for
driving an adaptive approach throughout billable departments to include championing
a risk-based approach to solve operational challenges.
Key Achievements:
• Instrumental in turning the company into a profitable venture within 7 months – from net annual
loss of $2mm+ to positive net profit year-to-year through realistic application of lean
methodologies.
• Drove development of leadership team by conducting group and one-on-one coaching sessions.
SHAUN H. WILLIAMS • Page Two • **************@*****.***
VIZTEK LLC, Garner, North Carolina • 2010
Digital Radiography Imaging Systems
Vice President of Operations
Led Software Development, Project Management and Implementation, Customer and Technical
Support, and Production operations of this leading provider of complete digital
software and hardware radiography imaging solutions.
Key Achievements:
• Achieved significant cost reductions through the development and implementation of multiple
new processes for company, to include staffing and travel management, sales order processing,
and call center operations.
• Improved the utilization of high dollar inventory and lowered overall costs.
TALECRIS PLASMA RESOURCES, RTP, North Carolina • 2008-2009
BioTherapeutics Manufacturer
Associate Director of New Center Development
(AD of Operations and Quality)
Led team of 20 management level personnel in all aspects of starting up and operating blood
plasma collection centers. Responsible for all aspects of 8 blood plasma collection
centers in six states, from construction and site selection through licensure by the
FDA. Centers were geographically dispersed operations that are regulated by the FDA
and operate under strict quality guidelines & standard operating procedures.
Key Achievements:
• Achieved FDA licensure for two plasma collection centers during a one week span – first ever
achievement for company.
• Successfully opened centers in multiple states to include staff selection and training, site
preparation – building, supplies and equipment, and business growth through licensure.
THINSPRING, Cary, North Carolina • 1999-2008
International provider of software & services to the life sciences industry
Partner & Director of Operations
Directed team of 10 management level personnel in all aspects of business operations. Devised and
executed strategies to reduce operating expenses, and enhance customer experience. Spearheaded
teams to craft improvements to quality systems and regulatory compliance programs. Established and
maintained relationships with clients and key vendors. Directed recruiting, organizational
development, as well as policy design and implementation. Created operating plans and detailed
business forecasts; managed corporate profit-and-loss statements.
Key Achievements:
• Directed the development of all company policies and procedures for this startup company.
• Oversaw 6-month initiative to submit and capture GSA Schedule 70 status as approved IT
products and services vendor to government agencies.
• Orchestrated business process improvement projects that remedied Consent Decree which
precluded $77M medical device company from selling products.
• Instituted robust quality systems and cGMP training solutions at a pharmaceutical manufacturer
that resulted in $100K in yearly cost savings and initiated creation of additional client quality
control project teams.
SHAUN H. WILLIAMS • Page Three • **************@*****.***
• Infused $100K in extra sales and service revenue by designing and implementing IT operations
and data center quality system for a blood products company that resolved non-compliance
issues with Title 21 Code of Federal Regulations (CFR) Part 11 standards for electronic records.
BESPAK, INC., Cary & Youngsville, North Carolina • 1997-1999
Global R&D and manufacturing organization serving the pharmaceutical market.
Plant Manager (Multi-plant)
Directed 120-person team in manufacturing operations at 2 respiratory drug delivery device production facilities.
Oversaw product engineering, production scheduling and yield, quality control, facilities and equipment
maintenance, as well as raw materials and finished goods supply chain management. Evaluated team member and
plant performance to ensure fulfillment of corporate objectives for productivity and profitability. Led training,
safety, quality, and compliance programs at both sites.
Key Achievements:
• Recruited to aid in strategic design, implementation, and launch of cutting-edge $10M
manufacturing facility to broaden market footprint and increase customer penetration.
• Led deployment of ERP solution integrated with all manufacturing and operating areas that
delivered $250K in annual inventory and logistics savings.
• Coordinated organizational restructuring in combination with operational cost-savings initiative to
maintain profitability after loss of vital client contract.
ALLEGIANCE HEALTHCARE CORPORATION, Jacksonville, Texas • 1990-1997
Manufacturer of biomedical equipment and devices spun off from Baxter International in 1996.
Business Manager / Production Manager
Formulated strategies to cultivate new business opportunities for $14M suction canister product line. Analyzed
manufacturing techniques and injection molding, thermoforming, assembly, engineering, and maintenance
operating procedures to streamline processes and drive critical quality improvements. Oversaw all plastics
processing operations within this world class facility. Key processes included injection molding, tubing and sheet
extrusion, injection blow molding, and thermoforming.
Key Achievements:
• Collaborated with colleague to convert traditional manufacturing plant into cellular manufacturing
facility for 4 major product lines, which was adopted enterprise-wide.
• Experienced substantial annual market share growth by achieving 5% in yearly operating cost
reductions, which translated into optimized price points.
• Lowered processing costs in all areas, leading to recognition as the low cost injection molder in
the corporation.
MILITARY EXPERIENCE
Captain (O-3), United States Army
EDUCATION
Bachelor of Science in Mechanical Engineering
United States Military Academy, West Point, New York