Quality Assurance Management

Steven E. Allison, MBA

**** ********* **** . ****** *****, IL 60081 . 815-***-**** .

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

Results oriented Quality Assurance Executive specializing in driving

transformational changes utilizing the Quality Management System as an

enabling function, managing large-scale IT projects in a GxP environment,

assuring regulatory compliance to domestic and international standards

while positioning quality as a competitive advantage.

Profile of Qualifications

. Proven quality professional leading global teams focused on Medical

Devices and Pharmaceuticals, as well as extensive QMS and IT experience

with GxPs encompassing such areas as Renal, Biological Science,

Medication Delivery, Clinical Manufacturing, Regulatory, and

Pharmacovigilance.

. Integral leader who excels in large-scale quality assurance / control

optimization, including designing, developing, and implementing forward-

thinking processes to achieve continued growth and productivity.

. Nationally certified Six Sigma Black Belt with talents implementing

Quality Management Systems, building Quality / IT teams, developing

Internal Auditing / Assessment functions, and partnering with key

suppliers.

. Top performer who demonstrates superior attention-to-detail and sharp

analytical abilities, including regularly taking the initiative to

identify and resolve issues and lead value-added projects to boost

success.

Professional Synopsis

Senior Director - Quality Management Systems

Johnson & Johnson, New Brunswick, NJ

(2011 - Present)

. Utilize broad scope of industry knowledge to direct enterprise-wide

construction and implementation of Quality Management Systems, including

addressing CFR Part 210 / 211, 21 CFR Part 820, and 21 CFR Part 11 across

all Medical Device and Diagnostic, Pharmaceuticals, and Consumer Products

Divisions.

. Lead construction of a Seven-Year Quality Systems Strategic Roadmap

encompassing elements of GxP Quality Systems while taking into

consideration the various IT-related components, and create a Management

Review Process to ensure strategically focused meetings to deal with

diverse tactical issues.

. Promote a Document and Data Control Department emphasizing configuration

management principals.

. Facilitate the rebuilding of QMS system and team in accordance with

requirements specified in ISO 13485 and 21 CFR Part 820, including

recruiting new talent while effectively handling department challenges.

. Rebuild CAPA process with focus on Root Cause Investigation with movement

toward proactive measures.

. Set long-term quality strategies and vision toward improving product

quality and core defect prevention.

Director - Quality Management Systems

General Electric Healthcare, Barrington, IL

(2009 - 2011)

. Strategically steered healthcare IT Quality Management Systems for 19

global sites encompassing Diagnostic Imaging, Enterprise Applications,

and all Clinical Business Systems compliant with QSR and ISO 13485.

. Constructed a complete and encompassing GxP Training Program which

allowed individuals to be compliant with extensive regulatory standards,

and promoted wide-ranging industry-specific certification programs.

. Built robust Global CAPA Program emphasizing incident investigation, root

cause analysis, and follow up.

. Created an Internal Audit & Assessment Program leveraging existing talent

pool, assisted in driving quality throughout all levels of business, and

created company ISO 13485 / 21 CFR Part 820 auditing program.

. Reworked Management Review Process to implement more strategically

focused meetings and process.

. Promoted a Document and Data Control area focused on solid configuration

management and principals.

. Rebuilt the QMS system and team in accordance with the requirements

specified in ISO 13485 and 21 CFR Part 820, including recruiting new

professional talent while proactively handing departmental issues.

. Introduced fundamental software quality concepts (e.g. walkthroughs, peer

reviews, Fagan inspections).

Steven E. Allison, MBA

815-***-**** . Page Two . **********@***.***

Professional Synopsis (continued)

IT Director - Quality, Regulatory & Pharmacovigilance

Baxter Healthcare, Vernon Hills, IL

(2007 - 2009)

. Built a world-class IT department and implemented business critical, 21

CRF Part 210- and 211-compliant IT systems, including initiating a $14-

million Global Adverse Event Monitoring and Reporting System, ARISg.

. Remediated legacy Adverse Event System, ORACLE AERS, and brought it into

key regulatory compliance.

. Successfully led delivery of a $4-million Phase I - Phase III (CTMS)

Clinical Trials Management System.

. Directed IT Project Managers responsible for proactive development and

implementation of key computerized systems supportive of Clinical,

Regulatory, and Pharmacovigilance business functional areas.

. Implemented a $6-million Documentum-based Enterprise Wide Content

Management System delivered within a 14-month timeframe, and enabled end

user business communities to achieve respective goals by providing the

appropriate technological-driven solutions based on building successful

client relationships.

. Handled multimillion-dollar budgets, as well as an additional $25+

million in capitalized project budgets.

. Managed globally based teams deployed in Germany, Vienna, California, and

diverse Illinois locations.

Associate Director - Quality Management Systems

Pfizer - Global Research & Development, Ann Arbor, MI

(2002 - 2007)

. Led targeted quality assurance efforts among a 20-building campus,

including overseeing all regulatory affairs, disaster recovery, software

validation services, clinical manufacturing, hardware qualification,

training programs, regulatory inspections, testing, and compliance with

21 CFR Part 211 and 21 CFR Part 11.

. Delivered resourceful international support for units in Brussels,

Singapore, Connecticut, and Michigan.

. Directed several state-of-the-art critical computerized systems,

including ARISg (Adverse Event Reporting), Oracle Clinical, and PIMS

(Phase I Clinical Data Capture), and Clinicopia (Supply Chain

Management).

. Mentored and managed solutions-oriented campus Quality Managers, Quality

Engineers, and Quality Auditors in quality-related activities associated

with clinical manufacturing, laboratory support, and computerized system

validation for cGMP, cGCP, and cGLP applications with 21 CFR Part 11

requirements.

. Led multimillion-dollar budget allocation for equipment, personnel

training, and talent development, along with operational staffing,

internal application development and procurement, and network

environments.

. Established all formal QMS and SDLC elements of Six Sigma, LEAN, CMMI,

GAMP, and ISO 13485: 2003.

. Directed an International Vendor Assessment Program, including qualifying

international vendors (e.g. India) based on objective evidence obtained

via examination of facility and analysis of quality systems.

Divisional Manager - Quality Systems / Transport

Ciena Corporation, Savage, MD

(1997 - 2002)

. Maximized operations success by directing compliance of 11 manufacturing

and software development engineering facilities in Maryland and Georgia

per ISO 9001: 1994 and ISO 9000-3: 1997 Quality Management standards /

guidelines, including coordinating quality management teams at key MD,

GA, and CA sites.

. Applied strong leadership talents toward directing 40 software, hardware,

and manufacturing auditors throughout Maryland, Georgia, and California

as part of an Audit / Business Process Assessment program.

. Led successful implementation and registration of ISO 9000-3 Guideline

Requirements for Software Quality, and implemented the forward-thinking

organization's QMS registration upgrade to ISO 9001: 2000.

. Maximized bottom-line results as point-of-contact for sales / marketing

regarding contracts, RFQs, and RFPs.

. Cost-effectively managed annual multimillion-dollar Quality System

departmental budgets while overseeing workflow of Quality System

Engineers, Document and Data Control Specialists, and Metrology teams.

Steven E. Allison, MBA

815-***-**** . Page Three . **********@***.***

Professional Synopsis (continued)

Manager - Quality Assurance & Operations

Spectral Responsibilities, Inc., Duluth, GA

(1995 - 1997)

. Played a vital role in planning and executing companywide ISO 9002

Quality Management System pre-assessment and registration assessment

activities administered by Underwriters Laboratories, including

establishing a defined QMS, coordinating personnel workflow, and

participating in an Operations Group.

. Established quality control / assurance system procedures including SPC,

Process Capability, and Control.

. Developed and implemented a closed loop Corrective and Preventative

Action System using Lotus Notes.

. Increased key throughput, reduced scrap, and improved product test yields

across all manufacturing lines.

. Demonstrated solid multitasking abilities toward creating a companywide

Internal Audit & Assessment program; collaborating with engineering

leaders in resolving design issues with BGA and SMT PCB Assemblies per

IPC-A-610 standards; and participating in an Operations Group responsible

for purchase of capital equipment, resolution of inventory issues,

facility expansion, staff recruitment, and customer selection.

Quality Assurance Manager

Emerson Electric Corporation - CIC Division, La Vergne, TN

(1994 - 1995)

. Expertly redirected the company's multi-facility Quality Assurance,

Inspection, and Testing programs, including effectively restructuring,

developing, documenting, and implementing a standardized Quality

Management System based on ISO 9001 Quality System Requirements to boost

operations productivity.

. Coordinated and led details-focused final inspection, test, repair,

warranty, and warehouse department teams.

. Decreased number of product warranty and return claims 20% while handling

all customer complaints.

. Recognized for job excellence as winner of 1995's "Tennessee State

Quality Award for Small Business."

Education & Professional Development

Master of Business Administration

University of Michigan

Bachelor of Science in Industrial Technology

State University of New York

ASQ Certified Quality Auditor - Certification #31381

Business Process Audits & Assessments - 32 HR

RAB ISO 9001:2000 Certified Lead Auditor - 40 HR . RAB ISO 9001:1994

Certified Lead Auditor - 36 HR

ASQ Certified Software Quality Engineer - Certification #2648

Carnegie Mellon - Software Engineering Institute

Introduction to CMMI Staged Representation, v1.1 - 24 HR

ISO 9000-3:1997 Software Quality System Implementation - 24 HR

ASQ Certified Quality Manager - Certification #7566

GCP / GMP / GLP Orientation - 32 HR

FDA Auditing of Computerized Systems - 24 HR

21 CFR Part 11 - 8 HR

ASQ Certified Six Sigma Black Belt - Certification #3499

Excellent Professional References Provided Upon Request

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