Quality Assurance/Quality Systems Manager

SUMMARY

Quality Assurance professional with over 20 years of experience with API

manufacturers, and branded and generic pharmaceutical companies.

Particular emphasis on designing, harmonizing and implementing quality

systems, training/development programs and document management. Extensive

knowledge of Q7 and ICH guidelines. Specialized in GMP training, quality

standards, auditing, quality investigations, batch release, computerized

systems validation and electronic document management. Excellent

facilitation, negotiation and leadership skills.

PROFESSIONAL EXPERIENCE

SPI Pharma Inc., Delaware 2011-Present

Site Quality Head of QA and QC (2011-)

Managed multi-site Quality department's staff of 20 for API manufacturer,

to include Quality Assurance, Quality Control and Analytical Development.

Proactively prepared site for FDA inspection; zero 483 items. Prepared

excipient site for ISO 9001 certification; awarded.

. Partnered with Corporate to standardize quality systems across sites.

. Finalized qualification of new microbiology laboratory and renovation

of production suite.

. Hosted external audits and managed commitments.

. Liaised with customer service and production with investigations of

customer complaints.

. Incorporated Document management process and initiated EDMS

initiative.

. Managed department budget; $2M

Caraco Pharmaceutical Laboratories, Ltd., Michigan 2010-2011

Senior Manager, Quality Assurance (2010-2011)

Oversee quality assurance functions with staff of 23 professionals.

Organization under FDA Consent Decree. Interact with FDA to assure

compliance with current standards. Restructure quality systems for solid

dosage and third party manufacture.

. Partnered with business organization to design quality into the

product.

. Improved Change Control program.

. Developed Vendor Qualification program.

. Provided professional expertise during investigations,

corrective/preventative actions and revalidation activities.

. Redesigned document control facilities and practices.

. Approved Contract Manufacturer change control.

Watson Pharmaceuticals, Inc., Utah 2007-2010

Manager, Quality Assurance (Documentation, Lot Release and Quality

Operations) (2007-2010)

Managed department responsible for batch release, electronic document

management system, archival and change control of GMP documents.

Championed continuous improvement projects within quality organization for

commercial distribution of transdermal products. Responsible for QA

approval within TrackWise and EDMS (Livelink) for R&D documentation and

commercial product.

. Empowered 10 direct reports, 21 overall staff.

. Increased change control process flow by 70%.

. Spearhead redesign of Batch Records reducing entries by 60%.

. Increased efficiency of document retrieval by 65%.

. Represented QA organization during design and implementation of global

ERP system (JD Edwards).

Pfizer Inc., Michigan 1992-2007

Quality Systems Head, Esperion Therapeutics, A Pfizer Inc. Co, (2007-2007)

Managed all quality systems (document control, training, quality

standards). Championed implementation of integrated standard operating

procedures.

. Developed 100% of Esperion quality standards to align with Pfizer,

Inc.

. Managed and maintained all quality standards from creation through

archival status.

. Partnered with all Esperion business lines to establish gap analyses

and implementation plans for quality standards.

. Conducted training sessions for over 70 professionals on critical GMP

topics and quality standards.

. Developed document management system for global access.

Senior Scientist, Global RegCMC and QA (2006-2007)

Administered the global standard operating procedures program. Championed

global implementation and design of change control for GMP documents.

. Administered the standard operating procedures program for over 280

quality standards and practices utilized by more than 2000 colleagues

globally.

. Coordinated the electronic review and approval of more than 70 global

standard operating procedures annually.

. Designed global change control policy as life cycle management for GMP

documents.

. Led over 30 Limited Duration Teams to incorporate new requirements of

change control policy into workstream processes with revisions to

standard operating procedures within a six month timeframe.

. Championed global standardization and management of planned temporary

deviations.

Senior Principal Scientist, RegCMC and QA (2003-2006)

Managed the 21 CFR Part 11; Electronic Records, Electronic Signatures

remediation team for newly acquired Kalamazoo, Michigan site. Designed and

administered global document management system (Documentum). Championed

global implementation of standardized quality systems and workstream

processes.

. Coordinated more than 200 remediation activities related to Part 11

compliance for computerized equipment and systems. Supervised 6

consultants.

. Coordinated document migration activities from three legacy docbases

to a single global document management system within one year.

Supervised 5 consultants.

. Led Limited Duration Teams to develop and implement standardized

business practices - 8 local, 6 global.

. Coordinated and conducted site implementation activities for over 85

global standardized practices; 53 of those within four months.

. Served as Site Administrator for global document management system.

. Provided expertise on electronic document management to Corporate

records retention and supply chain workstreams.

. Developed six electronic workflows for four different workstreams in

order to utilize electronic signatures on documents managed within the

global document management system.

QA Manager, Regulatory & Quality Operations (2001-2003)

Managed GMP training activities for reorganized pharmaceutical sciences

group. Championed the 21 CFR Part 11; Electronic Records, Electronic

Signatures remediation team. QA Lead for MRP implementation.

. Closed 35% of the 21 CFR Part 11 compliance gaps across 80

computerized systems by authoring eleven global procedures.

. Coordinated and conducted more than 80 compliance gap analyses of

computerized systems over four months.

. Reviewed and approved validation documents for one global and seven

local computerized systems within one year.

. Trained over 300 technical professionals on various cGMP topics on a

quarterly basis.

. Partnered with global GMP trainers annually to design core GMP

training programs for the corporation.

. Coached 20 quality assurance professionals on training techniques for

cross-functional ability to conduct GMP training programs.

. Collaborated with business line managers to develop a 3-tiered

colleague professional enhancement program.

. Partnered with other quality assurance professionals across 5 global

sites to harmonize quality systems within research and development.

. Served as QA representative for a drug substance facility on 4 global

system harmonization teams.

. Partnered with Production, Warehouse, Inventory Management and QA to

design and implement new MRP system within 9 months.

. Served on Change Control Board as global QA representative for MRP

system.

Senior Quality Assurance Administrator, Holland Laboratories (1992-2001)

Assured compliance with quality systems for drug substances used in

manufacturing toxicological and clinical supplies.

. Developed and administered at least 5 quality systems that increased

the regulatory compliance status of the facility according to 21 CFR

Parts 210, 211.

. Improved the compliance of GMP documentation by 40% through the

quarterly presentation of various GMP training courses to 100

professionals.

. Approved and supported the shipment of at least 50 lots of drug

substance per year by reviewing over 250 associated manufacturing

records for compliance with regulatory and departmental procedures.

. Reviewed and approved over 80 analytical data packages per year to

verify information contained in certificates of analyses, method

validation reports, research reports and IND submissions.

. Improved the compliance of the facility by conducting quarterly

internal audits and partnering with Corporate Quality Auditors.

. Assured compliance with GMP regulations and company standards through

partnership and collaboration with research scientists for over 250

manufacturing records per year to support the production of drug

substance.

Aldrich Chemical Company, Milwaukee, Wisconsin 1983-1992

Administrative Chemist/Information Specialist, President's Office (1988-

1992)

Coordinated the research efforts of the scientists by providing synthetic

routes for new compounds.

. Conducted on-line literature searches to obtain journal articles and

patents for potential development of new compounds for the Aldrich

Catalog.

. Communicated to corporate management the progress of global research

and development activities on a monthly basis.

. Provided assistant to customers with catalog inquiries and complaints

as a technical services consultant.

Chemist II, Specialty Products Department (1986-1988)

. Developed new optically active compounds for inclusion in the Aldrich

Catalog by utilizing various chemical syntheses, isolation and

purification techniques.

. Monitored purity of developed compounds using several analytical

techniques: NMR, IR, UV, GC and RI.

Chemist I, Isotopes Department (1983-1986)

. Prepared and purified isotopically labeled compounds to provide stock

for material listed in the Aldrich catalog.

. Supervised the stock status and product packaging activities.

. Trained 4 new chemists for growing department.

EDUCATION

BS, Chemistry, University of Wisconsin-Milwaukee

Executive Education Programs, University of Michigan Business School

Six Sigma Green Belt

Additional courses in:

. Training for GMP Compliance

. Auditing for GMP Compliance

. 21 CFR Part 11; Electronic Records, Electronic Signatures

. FDA Auditing of Computerized Systems

. Laboratory Equipment Validation and Qualification Management

. Applying Risk Assessment Tools

. Accelerated Learning Training Methods

. Clinical Trial Material Operations

. Project Management

PROFESSIONAL AFFILIATIONS

American Society of Quality

Society of Quality Assurance, GMP Specialty Section

American Society of Training and Development

GMP Training and Education Association

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