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A successful Director of Quality in the pharmaceutical industry, with a unique c

ombination of experience in R&D, Documentation Systems, Quality Systems and Comp


liance. Accustomed to working in a regulated environment with specific expertise
in modified release products in analytical development and extensive experience
in FDA pre-approval inspections, GMP inspections and regulatory submissions. Al
so experienced with Australian, Canadian, Japanese, and European regulatory agen
cies. Team oriented with highly developed technical writing skills and ability
to communicate at all levels on quality, regulatory and technical issues.
CORE COMPETENCIES
a Quality Leadership and Management
a Technical Writing
a International Regulatory Compliance
PROFESSIONAL EXPERIENCE
MFL Pharma Quality Compliance
Principal Consultant. 2009
An independent consultant specializing in cGXP auditing, compliance remediation
and continuous improvement.
DPT Labs, Lakewood, NJ
Director Quality Systems. 2007 - 2009
DPT is a contract development and manufacturing facility that has supported cust
omers with numerous FDA approvals and continues to support customers in commerci
ally producing over 300 OTC and Rx drug products, cosmetics and medical devices.
DPT has recently focused on the development of aseptic manufacturing process a
nd nasal delivery systems.
Responsibilities: As head of quality for the site was directly responsible for q
uality and compliance for commercial and R&D operations. Responsible for all si
te and corporate quality systems and was the lead person during FDA audits. QA,
QC, Documentation Control, Quality Engineering and Validation reported to this p
osition. The Director reported to the VP Quality Systems who is located in the
corporate head office in San Antonio.
Major Accomplishments: Introduced TRACKWISE for the investigation and complaint
process. This resulted in higher customer satisfaction as measured by survey.
Also implemented EDUNEERING as a solution to training needs resulting in better
compliance with customer expectations. Provided leadership for the implementati
on of USP <467> residual solvents and negotiated a resolution to client specific
FDA483 observations. Enhanced both the CAPA and continuous improvement programs
for the site by analysis of trends in deviations and complaints. Managed succe
ssful site transfers for 10 major products from a key customer during a 6 month
period.
Vivus Inc, Lakewood, NJ
Director Quality Systems. 2003 - 2007
VIVUS develops proprietary products for the treatment of sexual dysfunction. Th
e commercial production site is located in Lakewood, NJ.
Responsibilities: As head of quality for the organization directed the quality a
nd compliance function for the manufacturing site. Also provided QA and complia
nce support for the R&D program. Responsible for all site and corporate quality
systems, QA, QC, Document Control, Facilities, Technical Services and Validatio
n reported to this position.
Major Accomplishments: Author or major contributor, reviewer and approver of the
Quality Manual, Site Master File, SOPs, validation protocols and reports, Inves
tigations, Annual Product Reviews and Annual Reports for the US, Europe and Cana
da.
Gibraltar Associates
Consultant in Quality, Regulatory and Compliance 2003
Alpharma USHP, Elizabeth, NJ (now Actavis)
Director Quality Research, Global Scientific Affairs, Alpharma. 2003
A new position created to direct companyas approach to the FDAas initiative on a
Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach.a
Purepac Pharmaceuticals, Elizabeth, NJ (acquired by Alpharma in 2001)
Director, Quality Assurance, 2000 a" 2003
3 sites Elizabeth NJ, Piscataway NJ, Memphis TN.
Purepac developed, manufactured and distributed generic solid oral dosage forms,
both immediate and modified release, of Rx Pharmaceuticals.
Responsibilities: Directed and implemented Quality Policy and Procedures, includ
ing functional and administrative QA systems for three sites. As senior quality
manager was responsible for setting quality standards for development, manufactu
re, testing, packaging and distribution of over 200 products. In addition to a c
ontinued responsibility for QA, has directly managed all areas of QA/QC for diff
erent periods of time including the QC Laboratory, Microbiology and Physical Tes
ting laboratory, Process and Cleaning Validation, and Documentation.
Major Accomplishments:
a Managed and directed the information for over 45 FDA inspections including pre
-approval and general cGMP.
a Reviewed and approved investigations, process and cleaning validation and equi
pment qualification documentation
a Developed and managed a comprehensive system for deviation investigations and
management for both the laboratory and production. Provided Quality Impact Asse
ssments for investigations.
a Acted for the Vice President of QA/QC on a regular basis, including developing
an overall budget for the QA/QC division and specific departments.
a Trained and mentored a number of quality professionals who became Directors an
d Site Directors
Director, Quality Assurance & Documentation 1996 - 2000
Major Accomplishments: As part of commitments to the FDA, the Director was respo
nsible for establishing and managing a central documentation function which form
ulated and implemented systems to manage key technical documents. The Documenta
tion Department became 30% of the total QA headcount.
a As project leader for electronic document control, identified and validated QU
MAS".
a Performed audits on external contactors and third party suppliers, resulting i
n 75% acceptance of contractors.
a Developed and implemented central change control.
a Managed Computer System Validation and Part 11 Compliance.
a Managed the introduction of a medical device, RAPIJECTa*, under the Quality Sy
stem Regulations at the Elizabeth plant.
a Provided support and documentation for over 50 regulatory submissions (NDA/AND
A/510K).
Director, Analytical Development 1993 a" 1996
Manager Analytical Development 1993
Major Accomplishments: As part of the R&D management group, developed strategies
for analytical development of modified release and immediate release solid oral
dosage forms. Also had responsibility for technical documents for product deve
lopment and support of existing. Managed and developed product specifications us
ing the USP and ICH and FDA Guidances.
a Established and directed cGMP compliance in the Analytical Development Laborat
ory, including interactions with FDA Inspectors during pre-approval inspections.
a Provided successful technology transfer for analytical test methods developed
for modified release products in Australia to the US site including Delayed-rele
ase Doxycycline, Extended-release Morphine and Extended-release Diltiazem.
a Developed and implemented training system and standards for laboratory staff.
a Planned and completed a major laboratory facility upgrade for R&D.
a Built department to a budget of $3M annually and up to 100 professional staff.
a Wrote original SOPs and updated existing.
Manager, Scientific Affairs 1992
Major Accomplishments:
a Provided expertise for the technology transfer of modified release products to
the US from Australia.
a Updated and upgraded the Stability function at Purepac. Installed, implemente
d and validated the Stability System" database resulting in on times studies and
faster ANDA and annual report preparation.
PREVIOUS EXPERIENCE
F.H. Faulding, Adelaide, SA, Australia
Group Manager, Drug Product Development
Manager, Analytical Development
Laboratory Manager, Analytical Services
F.H. Faulding, leading developer and manufacturer of Rx and OTC pharmaceutical p
roducts in Australia.
Major Accomplishments:
a Analyzed and developed test methods for extended-release products.
a Prepared documentation for regulatory submissions in Australia, Europe, Japan
and the US.
a Expanded R&D group and achieved increasing levels of management responsibility
and accountability
a Planned and brought on line a new R&D facility, a greenfield site in Salisbury
, Australia.
EDUCATION & TRAINING
Bachelor Applied Science, Chemistry and Microbiology (B. App. Sc.) (1981)
University of South Australia (previously South Australian Institute of Technolo
gy)
Regulatory Affairs Certification (R.A.C.) (1997)
Regulatory Affairs Professionals Society USA
Executive Development Program for Regulatory Professionals
Kelloggas School of Management, North Western University.
Regulatory Affairs Certification: Medical Devices (Currently Enrolled)
Regulatory Affairs Professionals Society USA
PUBLICATIONS
a Williams, D.B., Sansom, L.N., West, R.J., Boehm, G. Fong Lim, M.J. and Dwyer,
M.
Development Pharmaceutics and in vitro/in vivo Correlationas of Orally Administe
red Sustained release Theophylline. Proceed. Intern. Symp. Control. Rel. Bioact
. Mater., 16, (1989), Controlled Release Society Inc.
a West, R.J., Sansom, L.N., Williams, D.B., Boehm, G. and Fong Lim, M.J.
Pharmacokinetic Comparison of Enteric Coated Erythromycin Base Pellets (175 mg)
and Erythromycin Stearate Tablets (250 mg) in Healthy Volunteers. Antimicrob. A
gents and Chemother.