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SUMMARY
Unique combination of extensive experience and diverse skills in QA/QC, regulato
ry affairs, manufacturing and supply chain management that produce practical sol
utions that are compliant and effective. Experienced as a manager, individual c
ontributor and consultant in FDA regulated medical device and pharmaceutical ind
ustries. Professional working experience includes running large departments, co
ordinating outside resources and facilitating cross-functional teams in complian
ce with FDA, ICH and ISO requirements.
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CORE COMPETENCIES
Design and implementation of quality systems based on 21 CFR 210/211/820, ICH Q1
/Q7 and ISO 9001/13485 * Product Development Projects * Supplier Quality Process
es, design and implementation * Process and Cleaning Validation * Manage Stabili
ty Program * Integration of global standards and local procedures * Manage QA *
Manage QC lab * QA representative to partner programs * Lead cross-functional te
ams * Host regulatory agency and partner audits * Perform supplier audits * CAPA
program *Training * Investigations, complaints and deviations * Manage Producti
on * Regulatory Affairs, 510 (k) submissions, NDA and ANDA CMC sections * TQM fa
cilitator * Aseptic product manufacturing * Bioburden testing, environmental mon
itoring and sterilizer validation (steam and EO)
EDUCATION
B.S. MICROBIOLOGY, PENNSYLVANIA STATE UNIVERSITY
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PROFESSIONAL EXPERIENCE
NEKTAR Therapeutics, Huntsville, AL 2007-2010
QA Manager
Managed ICH Q7 Quality System, batch record review and release of PEG reagents a
nd pegylated API
* Selected to partner programs and development projects to ensure regulatory and
contract compliance
* Expanded QA facility support in process validation and cleaning validation to
increase effectiveness
* Formed cross-functional Process Control Team with QA and manufacturing to redu
ce deviations and improve interdepartmental communications
Manager QC/Stability
Recruited to develop and implement the ICH Q1A compliant stability program
* Improved reporting cycle time to enhance revenue flow for contracted stability
program and projects
* Increased program value with product profiles, adding graphing and data interp
retation
TADUNKLE CONSULTING, Lawrenceville, GA 2002 -2007
Quality Consultant, Contract Quality Engineer
* Clients and projects listed in attached table
KIEL LABORATORIES*, Gainesville, Georgia 1999-2001
QC Manager - Managed analytical unit that did raw material, finished product and
stability testing
Manufacturing Manager/ Regulatory Affairs Coordinator - Managed a manufacturing
unit that produced solid dosage and liquid dosage forms of generic drugs
* Set up production line and improved product throughput for new product launch
* Managed support testing and prepared 510(k) for new product that was FDA appro
ved
* Worked on CMC sections for several NDAs & ANDAs
MYELOTEC, INC., Roswell, Georgia 1997-1998
Director QA/RA - recruited to set up initial QSR compliant system and got FDA/IS
O approval
* Prepared an FDA approved 510 (k) submission for a spinal arthroscope and drug
delivery device
* Lead project that successfully obtained ISO 9001 certification and CE marking
* Implemented FDA 21 CFR 820, QSR including design control requirements
TADUNKLE CONSULTING, Quality Consultant 1996-1997
Hired as a consultant to design and implement ISO 9001 and FDA 21 CFR 820 QSR
* Ciba Vision, implement a design control system to comply with the QSR requirem
ents
* Basic quality system design for several Ciba Vision suppliers
BIOFIELD CORP., Roswell, Georgia 1994-1996
Quality Assurance Manager/Project Manager - Worked with CMOs/suppliers to develo
p and implement quality requirements for products
* Developed the project plans and facilitated the teams to support product devel
opment.
* Set up the complaint system and product specification master files.
* Coordinated the biocompatibility work required for FDA submissions and complia
nce with 21 CFR 58 and ISO 10993 requirements.
CIBA VISION CORPORTATION, Atlanta, Georgia 1980-1994
Manager of QA/C Test Labs - Managed 17 scientists and technicians for process su
pport, raw material testing and contract supplier management
* Facilitated TQM teams
Manager of Technical Relations and Vendor Compliance - Designed and implemented
the contract supplier management system
* Designed a contract supplier validation program to facilitate direct shipping
of CMO products into our distribution system
* Served on the steering committee that established TQM
Manager of Development Services - Managed a group of 60 scientists and technicia
ns including analytical chemistry, microbiology, statistics, toxicology and prod
uct quality assurance inspectors
* Directed the support testing and prepared data for Pre-Market Approval Applica
tions
* Successfully integrated technology from an acquired company into CIBA operatio
ns
* Developed testing procedures that lead to shorter development time for new pro
ducts
Manager of Quality Assurance and Statistical Services - Managed 12 people respon
sible for product inspection, release and a quality engineering group
* Using design of experiments, increased yields of lens blanks from 60% to 99%.
* Redesigned manufacturing processes to give over $1,000,000 a year in labor sa
vings
Manager of QA/QC - Designed QA system and QC laboratory support for a controlled
environment, device manufacturing facility
* Recruited and trained original staff for QA and QC departments in a successful
startup
* Completed USP water system, environmental controls and sterilization validatio
ns for facility approval by FDA

BURTON, PARSONS AND CO. INC., Seat Pleasant, Maryland 1975-1980

Director of QA and Assistant Director of QC - Directed operations QA at three si
tes that produced drug products manufactured in compliance with 21 CFR 210/211
* Lead project to successfully convert contact lens accessory production from 21
CFR 210/211 to the new medical device regulations, 21 CFR 820 requirements
* Recruited and trained original QA department
COMPUTER SKILLS
Computer user with experience in MS Word, Excel, PowerPoint and Visio
CONSULTING PROJECTS
Nektar Mar 2007 - May 2007
Quality system improvements, completed 2 years of annual product reviews, review
ed and approved developmental and stability project reports
Merial November 2006 - Feb 2007
Provided support work for the Director of Regulatory Affairs, animal drug produc
ts
LuMend (acquired by JnJ) Feb 2006 - June 2006
Upgraded quality system to integrate a device manufacturing facility with Cordis
systems
Cordis (Division of JnJ) June 2004 - Feb 2006
Quality system improvements and completed a global CAPA project to standardize b
ioburden assessment, environmental monitoring standards and sterilization valida
tion levels
Centocor (Division of JnJ) March 2004 - June 2004
Provided supplier quality system support and product development project support
Cordis July 2003 - December 2003
Supported Advanced R&D team by developing quality system documentation for new d
rug/device combination product
Cordis September 2002 - July 2003
Worked at a contract drug coated stent production site as a PIP, developing qual
ity system, clean room controls and documentation
Organon (Division of Akzo-Nobel) March 2002 - August 2002
Collaborated with the production group in a parenteral plant to rewrite manufact
uring SOPs and improve GMP compliance