Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

A quality, software quality, and management engineering systems professional, with more than 15

years of FDA regulated areas of experience, including (but not limited to) project management for

leading GxP projects and initiatives (i.e., mfg & production, lab environment, remediation, system

retirement, etc.), and conducting full scope validation effort, using SDLC methodology for

management of software and FDA related GAMP methodology for validation and qualification of

systems and equipment, as well as hardware, automation systems, utility systems for

pharmaceutical and medical device related quality systems.

Quality – Compliance - GxP

Quality Assurance –Validation/ Labs (SW Sys & automated equip) / Mfg Sys /Utility & HVAC

Systems

Medical Device Non Conformance and ISO 13485/ Medical Device

(PDP/Non-PDP) Corrective and Preventive Directive (MDD)

(CAPA) Action

Bulk Pharmaceuticals, OSHA Requirements Software Development Life

Chemicals Cycle (SDLC)

Sterile Parenteral Drugs Quality System Regulation CSV Deliverables: IQ/OQ/PQ,

MVP, VP, URS, FRS, TP,

(QSR) Compliance

Testing, TSR, VSR

Highlights

Project Analysis and Management System Analysis (Static and Dynamic) Systems Assessments System

Validation / Equipment Qualification FDA Regulation Compliance / 21 CFR Part 11, 210, 211, 58, 820 Change

Control Management and Review Periodic Review, Assessment and Evaluation

PROFESSIONAL MED DEVICE & PHARMACEUTICAL EXPERIENCE

Sr. Quality / Validation Consultant @ Smith & Nephew Corporation

Memphis, TN 11/11 – present

[Regulatory & CFR compliance, Software Quality, Quality, and GxP Initiatives]

• Provide quality, validation, and compliant subject matter expertise for regulated

industry GAMP and GxP rated environments.

• Validating system applications (SAP) and platform software systems and qualifying

associated equipment. As applicable, developed applicable validation deliverables IQ,

OQ, PQ documents in line with GAMP 5, risked based methodology. Ensure system

compliance with 21 CFR Part 820 regulations and corporate, global IT policy and local

site procedures.

1

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

• Performing gap assessment and evaluation of support and production systems,

including software, hybrid manufacturing systems and related documentation, in line with

cGMP, Software Development Life Cycle (SDLC), local policy and procedures, Smith &

Nephew corporate policy, and FDA regulations and guidance.

• Providing validation and FDA-related GxP consulting and quality advice (and

coaching) for compliance to Smith & Nephew global projects and regulated industry best

practices.

Sr. Quality Engineering Consultant @ St. Jude Medical Neuromodulation Division

Dallas (Plano), TX 9/11 – 10/11

[Regulatory compliance, QSIP, Quality System and new product development Initiatives]

• Performed assessment and review for new product development and post-

market evaluation, including customer complaint, hazard analysis and reconciliation, risk

assessment and risk management review and reporting.

• Compliance, corporate and local policy and procedures, and quality system

management methodology conducted in line with 21 CFR Part 820, as well as global

regulatory guidelines, regulations, and guidance methodology.

• Assessed, reviewed, and executed QS methodology, using design control

components for market, design, development, manufacture, and post-market

review and analysis phases.

Sr Computer Systems Validation Engineering Consultant @ CIBA Vision

Atlanta (Duluth), GA 12/10 – 8/11

[Software Quality, Quality, and GxP Initiatives]

• Perform evaluation and gap assessment of production system software, hybrid

manufacturing systems and equipment and related documentation, in line with cGMP,

Software Development Life Cycle (SDLC), FDA Part 11, Part 820 regulations, and global

and local Novartis and CIBA Vision Corp policy and procedures, respectively .

• Validate system software and related equipment, production process, and

developed applicable IQ, OQ, PQ documents for completion of MES upgrade, in

compliance with 21 CFR Part 820 regulations and local site policy and procedures.

External Validation Engineering Consultant @ St. Jude Medical

St. Paul, MN 5/10 –

9/10

[FDA required QSIP Initiatives]

• Performed effective assessment and evaluation of product Instructions for Use (IFU)

and Labeling practices, including development of specifications for product and package

labels for EnSite TM System, EnSite Velocity, and Array Catheter product lines, in line with

21 CFR Part 801 and 820 regulations.

• Reviewed and assessed related validation systems, equipment and documentation,

as well as developed applicable documents and execute appropriate level of equipment

qualification and process validation activities, to facilitate the implementation of Quality

Systems Improvement Project (QSIP) for product Instructions for Use (IFU) and Labels,

distributed to U.S. and global markets.

2

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

3

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

Sr SQE/ Boston Scientific, Site SQA Lead for Analytical / R&D Labs, Legacy Systems

Retirement Maple

Grove, MN 11/05 – 04/10

[Software Quality, Quality, and GxP Initiatives]

• Provided leadership in championing departmental and cross-functional

software quality assurance initiatives for site quality, process validation, and legacy

software/systems compliance and remediation activities.

• Led/managed SQA activities of corporate BSC process validation

remediation project

• Provided software quality and compliance-related leadership to analytical

and R&D laboratories, including system and equipment assessment, review, analytical

instrument qualifications, lab software-system validation of Laboratory software systems

(i.e., Labware LIMS, WinLIMS, Empower, etc.).

• Verification of work performance according to established Analytical and

R&D laboratories procedures, in line with SDLC methodolgy, GLP and GMP procedures .

• Managed Analytical an R&D compliance related independent review

processes of production and laboratory assay final data and investigative reports,

including Master Validation Plans, System Quality Plans, User Acceptance Tests

(UATs), and Functional Test Cases (FTCs) - to substantiate and justify software

parameter and configuration changes in support of product disposition and document

review.

• Coordinated strategic planning to develop and facilitate software system

and automated equipment retirement and related cross-functional team activities.

Sr. Validation Engineer (Lead Consultant @ Eli Lilly, Pfizer, and Baxter Pharmaceuticals)

Indianapolis, IN 12/04 – 11/05

[Quality Projects and GxP Initiatives]

• Led end-to-end project validation and quality initiates, including analyses,

validation activities for computer systems, medical devices, and manufacturing systems

(i.e. automation systems, lab systems, utility systems).

• Perform automated system and clinical data reviews and assessments, in

line with cGMP, cGCP and MDD (global) requirements.

• Verify compliance to corporate policies and procedure of automated and

clinical data acquisition systems, to include technical files information, and data integrity

and audit trail attributes.

• Led strategic planning to ensure/optimize cross-functional team development

and activities.

• Verify related consultant performance for conducting software alignment and

configuration, source code and firmware coordination of software systems for Analytical

and R&D laboratories.

• Responsible for managing pharmaceutical business process projects,

including development of diagrams, requirements and specifications, system architecture,

and configuration documentation and SOPs for development and execution of Installation

Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)

protocols, as required for analyzing and summarizing of protocol execution results and

creation of traceability matrices.

4

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

5

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

Sr. Validation Engineer (Consultant/Aerotek Engineering @ Eli Lilly R&D and HVAC),

Indianapolis, IN 5/03 - 10/04

[Quality Validation, GxP Initiatives]

• Provided consultant expertise to Fortune 500 Pharmaceutical Company, in line with

Corporate and local policies and procedures, and FDA regulations.

• Led project validation and quality initiates, including system assessments, analyses,

validation activities for computer systems and manufacturing systems (i.e. utility systems,

HVAC systems, etc.)

• Implemented and conducted GMP and 21 CFR Part 11 validation engineering support

expertise, in support of CSV and HVAC compliance and validation activities.

• Analyzed and developed CSV project assessments, to facilitate the implementation of new

and remediation computer system validation efforts for site GMP and non-GMP related

computer systems compliance.

• Validated CSV program documentation, in line with GAMP and GMP/GLP regulations and

methodology, for the execution of the site and departmental (Master) Validation Plans .

• Conducted software configuration, alignment and coordination for R&D laboratory systems

Computer Systems Validation Consultant/Volt Tech Svc @ Eli Lilly/Tippecanoe Labs`

Lafayette, IN 6/02 – 4/03

[Quality, GxP Initiatives]

• Performed successful and effective analyzing and evaluation of project assessments,

including development for corrective actions and interim strategy protocols, to facilitate

the implementation of system replacement and reinstallation for CSV and IT computer

system validations and computer compliance activities and processes.

• Analyzed and developed CSV project assessments to facilitate the implementation of

new and remediation computer system validation efforts for site GMP, including document

development in support of 21 CFR Part 11 Compliance, as well as, non-GMP related

computer system compliance.

• Validated IT computer compliance program computer systems, in line with cGMP

guidelines; as well as, OSHA and ISO guidelines.

• Developed validation deliverables (i.e., requirements, specifications, test plans, etc.)

per appropriate scaling plan for the execution of the Site Master Validation Plan.

IT Validation Engineer (Consultant), Pfizer/Pharmacia,

Augusta, GA 4/00 -

6/02

[Quality, GxP Initiatives]

• Performed successful and effective review and evaluation of industrial, agricultural,

and FDA/cGMP compliant operations, including procedural development, IQ/OQ/PQ, FAT

qualifications & testing, in support of 21 CFR Part 11 compliance and validation and plant

Start-up activities.

• Reviewed operational guidelines and procedures for the evaluation and assurance of

process compliance to all manufacturing and maintenance systems via current Good

Manufacturing Practices.

6

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

• Executed validation protocols to ensure the compliance of operational, installation and

performance qualifications to current ISO 9001 and FDA/cGMP regulations and

guidelines.

Quality Assurance Validation, Test and Training Development Consultant, GA Depart –

Tech Educ., Vidalia, GA 5/98 – 4/00

[Quality Mfg/GMP, ISO, and Training Initiatives]

• Successfully and effectively developed corporate training plans, using Performance-

Based Training (PBT) methods for new and expanding businesses throughout the State

of Georgia.

• Conducted statewide program needs assessment, design of instructional training

packages - to include training master plan, job and task analysis, needs analysis, etc. for

all employment training phases.

• Designed company/product specific operational procedures and training programs,

including quality assurance tests for specific manufacturing processes. Conducted

extensive general post-employment training:

o ISO 9000 and OSHA Overviews

o Powered Industrial Equipment Safety Training

o General Plant Safety, including Lockout/Tag out, Hand Tool Safety, Ergonomics,

etc

MILITARY

DOD Deputy Facility Systems Commander, 1Lt / United States Air Force

Performed and maintained quality analysis via site computer and control operations.

Performed duties as a Combat Crew Commander of a Department of Defense (DOD),

Titan II Nuclear Missile facility.

Monitored, controlled and maintained missile systems readiness via electronic, hydraulic,

pneumatic and HVAC systems.

Performed computer analysis of missile systems and additional facilities systems (i.e.,

electronic, hydraulic, pneumatic and HVAC systems).

Supervised and monitored missile and facilities systems for electronic, hydraulic,

pneumatic and HVAC systems.

Managed up to 35 personnel for site systems analysis, maintenance operations,

personnel training and facility systems upgrade activities, as well as, training on good

computer practices and good documentation practices for security, safety and

communications systems.

EDUCATION

B.S. Degree – Biology/Chemistry, Alabama State University (1979)

M.B.A. Degree – Industrial Technology, Almeda University (2012)

7

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

8

Curriculum Vitae

FRANK J MADDOX JR

(Mobile) 612-***-****

aca0gf@r.postjobfree.com

Specialized Training:

Regulatory Affairs System Analysis

Quality System Regulations

Design Control Analysis

USP Analytical Method Validation

Analytical Instrument Qualification

Process Validation / FMEA

Quality Systems for Managers

HAZWOPER (HAZMAT & Hazardous Worker Ops)

DOE Classroom Skills Implementation

DOE Curriculum Design / Development

Chemical Operations and Analysis

DOD Facility Systems Analysis

References provided upon request

9

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