Manager Quality

SHAUN H. WILLIAMS

**** ******** ******, #*** ( Raleigh, North Carolina 27606

919-***-**** ( abi5nm@r.postjobfree.com

http://www.linkedin.com/in/shaunwilliams

OPERATIONS PROFESSIONAL

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 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. Fluent in English and German languages

with international experience. Previously held TS/SBI security clearance.

Strategic & Business Planning ( 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 ( Compliance

PROFESSIONAL EXPERIENCE

VIZTEK LLC, Garner, North Carolina ( 2010

Digital Radiography Imaging Systems

Vice President of Operations

Responsible for leading 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:

. Developed and implemented multiple new processes for company, to include

staffing and travel management, sales order processing, and call center

operations.

. Initiated steps to help improve the utilization of high dollar inventory

and lowered overall costs.

TALECRIS PLASMA RESOURCES, RTP, North Carolina ( 2008-2009

BioTherapeutics Manufacturer

Associate Director of Operations and Quality

Led team of up to 20 management level personnel in all aspects of starting

up and operating blood plasma collection centers. Responsible for all

aspects of up to 8 blood plasma collection centers, 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.

SHAUN H. WILLIAMS ( Page Two ( abi5nm@r.postjobfree.com

THINSPRING, Cary, North Carolina ( 1999-2008

International provider of software & services to the life sciences

industry.

Director of Operations

Directed team of up to 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.

. 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 CORPORATION (Formerly Baxter Healthcare), Jacksonville, Texas (

1990-1997

Manufacturer of biomedical equipment and devices spun off from Baxter

International in 1996.

Business Manager (1994-1997)

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.

SHAUN H. WILLIAMS ( Page Three ( abi5nm@r.postjobfree.com

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.

Production Manager (1992-1994)

Managed 120-person, 24x7, $45M medical device production operation with

$8.5M annual budget. 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:

. Lowered processing costs in all areas, leading to recognition as the low

cost injection molder in the corporation.

Various Positions (1990-1992)

Held positions as Production Supervisor, Staff Engineer, and Quality

Systems Engineer.

MILITARY EXPERIENCE

Captain (O-3), United States Army

EDUCATION

Bachelor of Science in Mechanical Engineering

United States Military Academy, West Point, New York

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