Gregory Rhead

Address: *** ******** *****, *** ***** CA, US

Mobile: + (1-720-***-****

Email: acw92u@r.postjobfree.com

QUALITY MANAGEMENT / BUSINESS STRATEGIST

Highly competent management professional offering over 25 years of

strategic management expertise and technical leadership within the

manufacturing and production domains. Acquired excellence in managing start-

ups and process restructuring projects utilizing critical analysis,

management intellect, and business acumen. Well versed in quality standards

including FDA, EMA, HC, JN, and CFDA including QSR and ISO along with

expertise in assessing quality requirements of operational processes while

offering customized solutions on modifications and alterations as well as

implementation of new processes. Outstanding track record of successfully

implementing process reengineering initiatives including change management

and lean Six Sigma methodologies targeted at increasing efficiency,

improving output and time through effective utilization of resources.

Currently seeking an opportunity to work with dynamic management teams in

formulating top-level decisions within highly competitive international

market scenarios while realizing shared business objectives.

CORE COMPETENCIES

Quality Management ? Cross Functional Leadership ? Compliance with

Legislation ? Process Improvements ? Product Development ? Start-Up

Operations ? Large-Scale Production ? cGMP / GLP ? P&L ? Financial

Projections ? Polices and Procedures ? Corporate Strategies ? KPIs ?

Project Management ? Analytical Method Development ? Chromatography ?

Analytical Control Systems ? Biological Formulations ? Quality Control

Systems ? Six Sigma ? IQ/OQ/PQ

KEY SKILLS

. Quality Management - Expertise in setting up and managing quality

management systems to ensure compliance with industry best standards.

Defining, implementing and controlling quality systems and performing

quality checking at all stages for ensuring desired outcomes. Engaging in

developing QA teams and QA strategy definition as well as implementing,

monitoring and reporting as per 21CFR Parts 820 and 211 (FDA), ISO 13485,

and ISO 14971 standards.

. Business Strategies - Skilled in handling company strategies while

specializing in delivery of a full-range of consultancy services

encompassing development of polices and procedures, corporate strategies,

budgets, key performance indicators, performance evaluation systems and

quality control systems. Acknowledged for mobilizing new business

operations across the globe in hi-tech and biological production

environments.

. Multidisciplinary Insights - Outstanding track record of achieving

performance improvement utilizing strategic analysis, analyzing costs,

managing vendors and contractors as well as mobilizing quality management

initiatives and logistics operations for ensuring operational excellence,

improved work performance, high ROIs and cost effectiveness.

. Board Liaison and Multidisciplinary Leadership Skills - Outstanding

ability in maintaining close cooperation with the board of management and

influencing decision-making processes at top levels. Excellent

communicator and negotiator comfortable working in a multicultural

setting.

KEY ACHIEVEMENTS

. Shipment Efficiency Analysis Projects: Responsible for managing multi-

million dollar projects delivering efficiency assessments across multiple

international locations while directing field research teams engaged with

over 300 SML enterprises involved in every aspect of the trade and

shipping pipeline.

. Established Supplier Quality Management Systems: Efficiently developed

and implemented multiple supplier quality management systems based on Six

Sigma methodologies. Identified and established critical part and product

specifications while achieving and maintaining the same throughout the

production process.

. Pioneered adoption of Advanced Product Quality Planning (APQP) in Medical

/ Biologics Methodology: Directed use of APQP methodology in the medical

device industry resulting in reduced patient risk and costs while

enhancing quality.

. Supplier Improvement - Efficiently directed the improvement of managing

and processing supplier corrective actions and developed tracking metrics

leading to reduction of process time to closure by 75% - from 8.5 months

to 2 months.

. Product Transfer Projects - Successfully led numerous technical and

biological product commercialization projects all within set budgets and

ahead of schedule.

KEY DELIVERABLES ACROSS CAREER SPAN

Quality Management

. Promoting quality achievement and performance improvement throughout the

organization through six sigma implementations.

. Developing, implementing, communicating, and maintaining a quality plan

in alignment with company's quality systems and policies in compliance

with quality system requirements.

. Effectively interacting with production and development teams to maintain

product supply and help introduce new products.

. Creating and managing necessary workflows and accountabilities to ensure

process development studies allow for routine commercial processes with

highest quality outcomes.

. Preparing technical documentation supporting change-management and

regulatory submissions. Provide routine process trending support to

identify critical process parameter trends and respond accordingly.

. Developing and managing the site validation master plan covering process,

equipment (IQ/OQ/PQ), room and equipment cleaning

. Ensuring a detailed project management approach is used during

implementation of technical transfers. Ensuring programs are designed to

achieve first time approvals from the FDA, EMA, HC, CFDA, and other

regulatory agencies and general cGMP

. Liaising with customers' auditors and ensuring the execution of

corrective action and compliance with customers' specifications.

. Establishing standards of service for customers or clients.

. Managing large Quality Teams including Quality Control labs including

Analytical, Biochemistry, and Microbiology laboratories.

Business Operations

. Gathering appropriate research data, during field-visits and desk-based,

in accordance with project requirements.

. Analyzing and interpreting data in the context of projects such as

benchmarking, process optimization, expansion, and, internal resources

development, among others.

. Directing and coordinating activities of businesses or departments

concerned with the production, pricing, sales, and/or distribution of

products; supporting client organization in development of vendors,

suppliers, and supply chains.

. Overseeing activities directly related to creation of products or

providing services.

. Directing and coordinating organization's financial and budget activities

to fund operations, maximize investments, and increase efficiency.

. Determining goods and services to be sold as well as setting prices and

credit terms based on forecasts of customer demand.

. Developing and applying commercial judgments post project analysis.

. Conducting appropriate financial projections and arranging project

finance.

. Establishing timeframes, required management support and funding for

execution of projects.

. Advising clients in developing and maintaining an enterprise view of

operations processes as well as identifying cross-functional relations

and interdependencies.

CAREER PROGRESSION

Principle Product Quality Leader - Large Molecule Nov 2014 - Present

Pharmaceuticals

Genentech, South San Francisco, CA

Director, Project Management - Logistics and Trade Jun 2012 - Oct 2014

Global Coalition for Efficient Logistics (GCEL), Geneva, Switzerland, Kuala Lumpur,

Malaysia, & Beirut, Lebanon

Senior Manager Quality - Medical Devices Jun 2008 - Jun 2012

Baxter International, Englewood, CO

Senior Manager Quality and Manufacturing - In Vitro Sep 2005 - Jun 2008

Diagnostics

Alere, Louisville, Colorado

Previous experience of over 15 years; commenced career in 1990 and

progressively handled variety of responsibilities pertaining to project

management, operations and quality management and accented career within

the field.

EDUCATIONAL QUALIFICATION

Bachelor of Science in Physiology Sep 1985 - Mar 1990

Michigan State University, East Lansing, Michigan

PROFESSIONAL DEVELOPMENT

. Biological Formulation

. Total Quality Management

. Quality Functional Deployment

. Business Intelligence

. MAC/Windows/Linux OS

. SPC / SQC

. APQP

. DMAIC

. Assay Development

. ISO9001/13485

. IQ/OQ/PQ

. LEAN / Six Sigma

References available on request

Contact this candidate