Quality Assurance Control

Brian R. Drumheller

**** ******* *****

Covington, GA 30014

H: 770-***-**** C: (770) 715 - 8685

************@*******.***

SUMMARY

Experienced Quality Assurance Professional Leader with 25+ years experience

in IVD and Medical Device Industries. Experienced in all aspects of

Quality Systems to include but not limited to; Design Assurance,

Production/ Process Controls (extrusion, molding, and packaging), Supplier

Assurance, Sterilization, Laboratories, and Distribution. Proven track

record of cost and process improvement achievements. Extensive

international experience.

PROFESSIONAL EXPERIENCE

C.R. Bard, Inc, Murray Hill, NJ 03/1991-Present

Medical Device Industry leader in Urological, Vascular Access, Hernia

Repair and Surgical products.

Corporate Lead - UDI Implementation, Operations/ Distribution - August 2013

- Present

Responsible for leading C. R. Bard, Inc. corporate-wide implementation of

Unique Device Identification (UDI) for manufacturing and distribution

sites. Manage site readiness projects for twenty manufacturing sites,

three company managed distribution centers (US, Belgium, Canada) and eight

3PL distribution centers. Lead or assist in development of corporate

standards regarding UDI compliance (e.g. label design requirements, bar

code format (GS1), GTIN assignment, and GUDID management). Drive facility

readiness for label generation, label inspection, and bar code processing

throughout the entire supply chain.

Director, Quality Assurance - Jan. 2004 - August 2013

Responsible for C. R. Bard Global Shared Services Organization

. Corporate Quality Assurance responsibilities for QA laboratories

(Analytical and Microbiological), environmental controls/ facility

qualification, biocompatibility determination, sterilization (EO,

Irradiation, Dry Heat) and distribution for all C.R. Bard locations,

worldwide.

. Quality Assurance responsibilities for large volume in-house EO

sterilization operation as well as manage over 18 contract sterilization

locations (US and OUS). Direct Quality Assurance management for three

company managed distribution centers (US, Canada, Belgium) and indirect

management of eight 3PL distribution centers in Asia, South America, and

other emerging OUS markets.

. Quality Assurance responsibilities for Corporate Packaging Laboratory -

conducting ISTA, ASTM, and ISO packaging standards testing.

. International Quality role - develop policies for international business

centers in areas of distribution and label control. Create Quality

Agreements with 3PL contractors. Interact with International Regulatory

group for OUS product launch plans, managing elements of product

registration, labeling regulations, and customs requirements.

. Participated in numerous product/ company acquisition projects, including

QA Lead for largest acquisition (at time of acquisition) in C. R. Bard,

Inc. history - lead QA elements of due diligence and integration for

temperature management systems company.

. Lead implementation of Wholesale Drug Distribution Licensing for Global

Distribution Center, implementing a drug pedigree process and gaining

VAWD accreditation.

. Qualified Global Distribution facility as Registered Human Tissue Bank.

. Identified and drove cost improvement projects in areas of endotoxin and

bioburden testing, environmental monitoring and sterilization validation

reduction - resulting in greater than $300,000 in cost reductions.

. Design Assurance experience/ New Product Development - managed Quality

Engineering team responsible for new product development projects

(disposable and reusable products, capital equipment). Participated in

creation of regulatory submissions for Class II medical devices.

. Developed Quality System for Pilot Operations in support of RD

objectives. Processes included chemical processing of porcine tissue and

lyophilization.

. Created European Sterilization Strategic Plan identifying $200,000 in

potential cost savings and established sterilization contingencies.

. Tasked with re-design of Division Stability Program - developing

documented justification for climatic conditions and creating standard

testing requirements/ protocols based on ICH guidelines.

. Identified and lead $ 800,000 Cost Improvement initiative, eliminating

gamma treatment/ sterilization processes for a dermal adhesive patch

product line.

. Extensive audit experience (internal and external) - facility lead for

hosting FDA, ISO, PMDA, TGA, and other regulatory bodies. Lead multiple

supplier audits (raw material, component, finished device, and services).

. Created numerous Corporate Standards in areas of Distribution Controls,

Sterilization, and Biocompatibility in effort to drive efficiency and

standardization.

. Re-designed Shared Service organization's CAPA program based on GHTF

(IMDRF) guidance. Team member, Corporate project to re-design CAPA

process. Primarily responsible for standardizing manufacturing metrics

threshold calculation.

. Management of Cold Chain transportation and storage requirements.

Developed corporate-wide training/ awareness program.

. ERP validation and implementation experience. In addition, lead

improvement programs, developing product hold functions for both J. D.

Edwards and MfgPro systems.

Division QA Operations Manager - Sept. 98 - Jan. 2004

Responsible for two manufacturing locations which included injection

molding, packaging, and EO sterilization. Managed Corporate Incoming

Quality Control laboratory responsible for component and finished goods

inspection (physical, chemical, biological testing).

. QA Team Lead for facility transfer of injection molding, packaging, and

sterilization operations. Facility shut-down and transfer to contract

manufacturing operation.

. Developed EO sterilization cycle, increasing sterilization capacity by

30%, while balancing safety (process and EO residual), product/ package

impact, and sterility assurance level.

. Lead successful outsourcing of In-house sterilization operations in

Southeast Asia.

. Responsible for Production/ Process Control for extrusion, injection

molding, packaging, and sterilization. Experience in process validation

and process monitoring for associated manufacturing methodologies.

Division QA Sterility Assurance Manager - April 94 - Sept. 98

Responsible for QA aspects of in-house EO sterilization operations

. Standardized Corporate EO sterilization validation/ adoption practices

. Active member of AAMI, member of EO and Microbiological Aspects Standards

Committees. Participated in development of EO, Irradiation, and

Microbiological related AAMI standards.

. Managed all microbiological aspects of production/ process controls for

divisional manufacturing sites and suppliers. Developed corporate

standards on environmental controls and product bioburden control/

monitoring, and endotoxin control/ monitoring.

. Expanded Incoming Quality Control Department to service Corporate OEM

business

Various positions; QC Supervisor, Microbiology Laboratory Supervisor -

March 91 - April 94

. Responsibilities included; Production/ process controls for manufacturing

and packaging operations. Management of microbiology laboratory,

including; sterility, bioburden, endotoxin, and cytotoxicity testing.

JRH Biosciences, Denver, PA 09/1987-03/1991

IVD Manufacturer of Cell Culture Media (dry powder and sterile liquid)

Quality Control Supervisor

QC testing and validation of cell culture media manufacturing, liquid and

dry powder. Aseptic fill and dry powder milling / blending.

. Responsibilities included validation of aseptic fill, dry heat,

autoclave, and de-pyrogenation processes as well as managing QC

laboratory and Lot Release functions.

EDUCATION

B.A., Biology, College of Charleston, Charleston, SC

TRAINING / COURSES

CCL Leadership Training, DMAIC, Lean Manufacturing Concepts, DOE, FMEA

ASSOCIATIONS

Member ASQ, PDA, AAMI

Contact this candidate