KENNETH F. MILES, PH.D., CQE, RAC, FRAPS

**** ***** ***** ******* **** Worth, Texas 76137 682-***-**** p1v3j2@r.postjobfree.com

QUALITY & CLINICAL/REGULATORY AFFAIRS

Certified Professional in Regulatory Affairs (RAC) with Regulatory Affairs Professional Society (RAPS). RAPS Fellow (2009).

Certified Quality Engineer (CQE), in American Society For Quality (ASQ).

GMP Institute Hall of Fame was created in 1991 to recognize top performers in the food, drug, medical devices, and cosmetic industries and other professional organizations and societies who have consistently demonstrated their commitment to the principles of Good Manufacturing Practices and Total Quality Management.

QUALITY & CLINICAL/REGULATORY AFFAIRS SKILLS

Executive Decision Making

Department Startup

GCP/GLP/GMP

Quality Systems

Risk Management

Validation Principles

Management & Leadership

Submissions (ANDA, NDA)

505(j); 505(b)(1) & 505(b)(2)

Internal/External Customer Relations

Drug Development Strategies (ICH/FDA)

Integration of Acquisitions Staff Recruitment & Retention

Program & Project Management

Strategic Planning

Quality Information Systems

Communication Skills

Manufacturing

Budget Planning Analysis & Control

Financial Planning & Management

Team Building, Mentoring & Leadership

Product Development/Life Cycle Management

Preparation & Submission of IND Applications Continuous Improvement

Training & Development

Performance Management

Policies & Procedures

Statistical Process Control (SPC)

Premarketing

Process Design/Improvement

Regulatory Affairs & Compliance Strategies

Technology Assessments & Investments

Organizational Management & Development

Participate in FDA Meetings

PROFESSIONAL EXPERIENCE

SOVEREIGN PHARMACEUTICALS, LLC Fort Worth, TX

Develop and maintain Quality & Clinical/Regulatory Affairs for the company. Generics

Vice President Quality & Clinical/Regulatory Affairs, June 2008 to May 26, 2011

Part of the executive management team that provides leadership for all Quality & Clinical/Regulatory Affairs activities. This position is responsible for driving product development programs, leading the Quality & Clinical/Regulatory Affairs function, directing the company’s clinical/regulatory initiatives, assuring the quality of generic products and processes, and ensuring the highest integrity in quality compliance & clinical/regulatory.

Key Results:

• Work strategically with the company’s R&D and clinical program leadership to align CMC, pre-clinical and clinical activities for the successful development and commercialization of therapeutics and associated products.

• Responsible for the design, planning and implementation of the company’s global regulatory strategy, and for initiating and maintaining effective communications with FDA and other regulatory agencies.

• Direct and oversee the timely and accurate preparation, review and submission of regulatory applications, amendments, reports and correspondences.

• Develop, implement, communicate and maintain a quality plan to bring the Company’s Quality Systems and Policies into compliance with quality system requirements.

• Effectively interact with Production and Development teams to maintain product supply and help introduce new products.

• Develop and maintain quality systems for the company in compliance with US FDA regulations.

• Manage the process of reviewing and revising the quality SOPs to comply with US FDA requirements.

• Recruit and train staff to comply with US FDA standards as well as reinforce training and motivate individuals.

• Create and manage the internal/external audit programs.

• Manage the quality control function within the manufacturing facilities and generic pharmaceuticals.

• Oversee oral solids and other dosage forms.

ANDRX PHARMACEUTICALS, INC. Fort Lauderdale, FL

Specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand name pharmaceuticals utilizing its proprietary drug delivery technologies. The company also markets and distributes pharmaceutical products manufactured by third parties.

Vice President Quality & Regulatory Affairs, April 2003 to June 2008

Reporting directly to the President, this position required an experienced business leader to re-shape the Quality Control and Quality Assurance functions to fully support the company’s rapidly growing business environment.

Key Results:

• Direct the development, implementation, and maintenance of a comprehensive written QA and QC Program to ensure that all drug products manufactured, processed, packed, and distributed by the Company, including any produced by third party, meet all safety and quality standards and potency that they are represented to possess.

• Provide technical expertise and recommendations to the CEO, Executive Committee, Board of Directors, and as appropriate to others in Company on day-to-day quality and compliance issues.

• Provides formal quarterly updates on the status of the Company's quality and compliance programs to the Board of Directors and CEO.

• Develop and assist business in implementation of appropriate compliance systems and programs working closely with the: VP of Operations, VP of Human Resources, CFO, and the CEO.

• Provides oversight to R&D to assure that the Company uses sound scientific product development and design practices with an emphasis on Quality by Design.

• Represents the Company during site visits by the FDA, DEA and key customer visits. Responds or reviews drafted responses to all 483s or customer audits and ensures all observations are corrected or addressed in a timely manner.

• Monitors and directs the completion of all formal commitments to the FDA, EPA, DEA, ATF, OSHA, or other regulatory bodies.

• Reviews all investigations of issues involving quality problems conducted by QA staff.

• Provides support as needed to supervisors to ensure appropriate corrective actions are taken in a timely manner.

• Monitors the implementation and verification of corrective actions to prevent future occurrence of NCR and deviations.

• Represents, the QA & QC functions of the Company to the pharmaceutical industry and government agencies for the purpose of promoting the Company and interests.

• Develop a comprehensive Quality Operations producing products based on “good manufacturing processes.

• Build and manage a Quality staff whose people will partner with Manufacturing Operations to solve quality problems while maintaining manufacturing efficiencies and meeting competitive business deadlines.

• Work closely with Manufacturing Operations in short and long term planning as it relates to quality improvements and compliance as well as best manufacturing practices.

• Manage quality operations within budgets and resource constraints.

MILES TECHNOLOGIES GROUP, LLC Panama City, FL

Consulting Firm specializing in quality and clinical/regulatory affairs.

Principal Consultant, 1996 – April 2003

Skilled in worldwide regulatory affairs, strategy development, quality systems, corporate-wide compliance, staff training and operational consulting to general management. Dr. Miles held senior level corporate regulatory affairs and quality assurance positions with Baxter Healthcare Corporate, Ciba-Geigy Corporation, Eli-Lilly and Medtronic Inc.

Key Results:

• Brought companies into compliance with U.S. FDA's cGMP's, ISO 9001/EN 46001 and UK Department of Health Services.

• Developed documents for regulatory submissions including: 7 IDEs; 12 510(k)s; 7 PMAs; 5 BLAs; 22 INDs; 18 ANDAs, and 2 NDAs.

• Established GMP/ISO training programs for managers, supervisors, and lead operators in manufacturing and manufacturing support groups.

• Developed and managed clinical studies that supported both United States and International submissions.

• Develop strategies for governmental approval to introduce new products to market, define global regulatory requirements, direct the preparation of submissions and negotiate approval with governmental agencies.

• Experienced Auditor for Good Manufacturing Practices and ISO 9000 Series Quality Standards and Medical Device Directives ISO 17025; ISO 14971; ISO 13485; ISO14969.

CIBA Geigy

Executive Director of Regulatory/Quality (1994 - 1996) Responsible for all matters relating to regulatory/quality and US FDA compliance activities for the following sites: Atlanta, Georgia; Grosswallstadt, Germany; and Batam, Indonesia. Serving as primary liaison between the company and the FDA and all other associated agencies, including agencies similar to the FDA outside the United States. Provide technical expertise to other CIBA sites and to international regulatory authorities during audits.

Eli Lilly

Corporate Manager of Regulatory/Quality (1991 - 1994) Accountable for the development of the Regulatory Affairs team to develop consistent processes, introduce best practices and identify improvement opportunities while leading efforts to ensure compliance with statues and regulations. Escorted and managed FDA investigators during FDA audits. Achieved successful GMP compliance turnaround and subsequent clean FDA audits (no FDA “483” report for six audits in 1993).

BAXTER CORP

Divisional Manager (1984 - 1991) Responsible for QA/QC departments for a manufacturer of in vitro diagnostic tests primarily used in commercial laboratories and hospitals including: Participate in product support activities including assisting in sales training and product launches, ensuring compliance with regulations.

MEDTRONIC INC.

Manager Regulatory/Quality (1970 – 1984) Developed a comprehensive Regulatory/QA/QC programs for the company, covering everything from incoming raw materials to finished goods inventory. Responsible for the majority of documentation submitted to various Federal Regulatory Agencies. Prepare 510(k) s, and PMAs. Interface with product transfer both domestic and International. Organized the setting up of two Puerto Rico and one Holland Plants. New product development from the laboratory through clinical trials. Provide technical support to sales and marketing and held training seminars for sales personnel.

EDUCATION & CERTIFICATIONS

Kennedy-Western University, Ph.D. Engineering

Kennedy-Western University, M.S. Engineering

University of Sussex, B.Sc. Chemistry

University of Minnesota, B.A. Physiology

Regulatory Affairs Professional Society (RAPS)

- Certified Regulatory Affairs - (Certificate # 317)

- RAPS Fellow (2009)

American Society for Quality Control (Senior Member)

- Certified Quality Engineer - (Certificate # 24740)

- Member of Biomedical Division

American Society of Metals International

GMP Institute Hall of Fame Award

- 1996 Recipient

International Society Pharmaceutical Engineers (ISPE)

Member # 54673

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