Quality Assurance Management

Curriculum Vitae

Twelve years of responsibility with Environment, Safety, and Health;

managerial and regulatory expertise and education in Industrial Hygiene

(IH), occupational health, facilities engineering; local, state, and

federal environmental practices, latest work safe laboratory practices;

ES&H and IH practices for worldwide occupation proficiencies in the areas

of pharmaceutical, biotechnology, with medical device FDA and GMP

manufacturing knowledge and experience. Experience in IH to include: air

sampling, noise, ionizing and non-ionizing radiation, confined space,

lighting, ventilation, respiratory protection, HAZWOPER certified;

conversant in environmental protection aspects with work experience that

includes the following:

. Direct the implementation and continuous improvement of corporate EH&S

policies and processes to laboratories and manufacturing facilities;

implement and revise safety plans and programs relative to operations of

facilities to ensure equipment and work plans are appropriately permitted

and functioning within applicable EH&S restrictions; experienced in the

review and update of R&D and manufacturing permits, plans, and processes

relative to environmental performance, employee health, and protection

programs;

. Experience as chemical, biological, and radiation safety officers,

responsible for the safe management of manufacturing and research

materials through the administration of storage and removal programs;

. Advise directors, managers and employees on alignment of their research

processes with corporate expectations; experienced in the negotiation,

development, and revision of contracts and bids, ensuring hazardous

materials are handled, stored, and shipped in accordance with regulatory

requirements; experience with vendor relations; including, preparing cost

estimates, scheduling correspondence and purchase requisitions for

assigned laboratory and vivarium projects;

. Identify and lead site training and deliver customary laboratory

communication to enhance work process knowledge of IH programs related to

building mechanical systems and utilities; local, state, and federal

construction codes and regulations, with an understanding of laws

pertaining to construction and environment and energy conservation.

Plan, budget, and schedule facility modifications, including estimates on

equipment, labor, materials, with additional related expenses;

. As RSO have the responsibility to review proposed experimental protocols;

monitor ionizing radiation levels for employees for over ten years;

ensure proper controls are present and adhered to in accordance with

applicable Cal/OSHA, and California Radiation Health Branch Regulations,

with practice of ALARA to reduce individual radiation health hazards;

. Develop and implement self- assessment protocol training, ensuring

employees are competent in assessing health hazards with chemical,

biological, and physical hazards, i.e. air sampling, noise, ventilation,

radiation both non and ionizing, stationary and mobile sources surveying;

. Expand appropriate EH&S didactic training; provide consultation,

education, and training for management and staff to recognize related

risks inherent in their role of employment; established areas of

responsibility for industrial hygiene and environmental areas of

commitment; ability to ensure compliance with Cal/OSHA, EPA, DOT, cGMP

and FDA, with Occupational Health Regulatory Divisions;

. Report laboratory work performance to senior management and R&D advocates

associated with research and manufacturing corporate audits results;

issue correction notices for violations; conduct follow-up inspections to

ensure correction of deficiencies by instructing and advising involved

personnel. Ensure employees are trained in the safe use of the equipment

managed; investigate exposure incidents and complaints with written

follow-up reports with GLP and cGMP regulations;

. Establish and maintain intranet team site for training learned, work

planning packages, and intranet tools to aid those planning and

authorizing work; provide counsel and training to management, laboratory,

and manufacturing personnel towards successful completion of audits and

inspections; provide needs assessments and program development, for

managing environmental training curriculum specifically developed to

instruct employees on disaster survivability.

Educational Experience

PEPPERDINE UNIVERSITY, Malibu, California

MBA, Administration & Organizational Studies, Two year study program

Leadership and Management Programs with Business Law

CALIFORNIA STATE UNIVERSITY FULLERTON, Fullerton, California

BA, Business Administration, Four year study program

Managerial Accounting and Finance with Business Law and Statistics

SANTA ANA COLLEGE, Santa Ana, California

AS, Mechanical Engineering with Architectural Design, Three year study

program

Design and Construction of Manufacturing Facilities

UNIVERSITY OF CALIFORNIA SANTA CRUZ, Santa Cruz, California, Two year study

program

Certifications, Occupational Health & Environmental Health and Safety with

Hazardous Materials Management

Occupational Health Law with Environmental, Health, & Safety with Hazardous

& Biological Materials Safety

UNIVERSITY OF SAN FRANCISCO, San Francisco, California, one year study

program

Certification, Occupational Health Services with Financial Administration,

Managed Health Care Finance and Corporate Law

UNIVERSITY OF CALIFORNIA IRVINE, Irvine, California, Two year study program

Molecular Nuclear Medicine with Radiopharmacy: California State License RHN

1527

Radiopharmacy with Developmental Biophysics, Biological Sciences, and

Biochemistry development programs; acquired theoretical knowledge and

practical experience to assume responsibility for the small-scale

production and quality control of radiopharmaceuticals; developing and

setting mandatory occupational safety and health standards involves

determining the extent of employee exposure to radiation hazards and

deciding what is needed to control these hazards, thereby protecting the

workers.

UNITED STATES NAVY, SSBN Dolphins Qualified - Presidential Unit Citation -

Four year enlistment

Qualification EHS with IH training, Hospital Corpsman Submarine Service, S2

Reactor with Weapon Programs

Advance medical and environmental training to anticipate, recognize,

evaluate, and recommend controls for environmental and physical hazards

that can affect the health and safety of the crew.

2010 - 2011 Certification with Continuing Education Curriculum

. Extensive working knowledge and understanding of all applicable

practices & techniques, laws, project

. Controls and environmental regulations to include Cal/OSHA and Federal

OSHA safety regulations

. Department of Transportation (DOT) certified

. International Air Transport Association (IATA) certified

. Current Good Manufacturing Practices (cGMPs) with applicable Cal/OSHA

regulations

. 10 Hour Construction Safety with Fall Protection Training and Lockout-

Tagout (Hazardous Energy Control)

. Good Laboratory Practices (GLPs) with applicable State and FDA

regulations

. Occupational Health and Ergonomics California/OSHA and Federal/OSHA

. Health Insurance Portability and Accountability Act (HIPAA)

regulations

. National Institute of Health (NIH) & Center for Disease Control (CDC)

Biological Safety Level 2+

. Hazardous and Medical Waste Management - Biological and Chemical

Respiratory Protection Training

. 40 hour Hazardous Waste Operations and Emergency Response Training

(HAZWOPER) OSHA1910.120

. Radiation Safety Officer, USN Instruction

. Potent Compounds Exposures with Clean Air Compliance and Waste

Classification

. Incident Investigation and Root Cause Analysis with Clean Water

Compliance with Release Reporting

. Process Hazard Analysis (PHA) for Facilities and Environmental

Programs

. Hazardous Waste Management and Spill Response Certified

Work Experience

SIRNA THERAPEUTICS/MERCK, SHARP & DOHME PHARMCETUICALS

August 2008 to Present

Senior Manager Environmental, Health & Safety with Occupational Heath and

Radiation Safety

research biotechnology, san francisco, california

Proficient to independently develop and implement Environmental,

Safety, and Occupational Health policies and procedures consistent with

local, state, and federal regulatory requirements. Able to review and

assesses workplace health and safety risks, and advice both employees and

managers on how to minimize or eliminate risk in their workday.

Assure chemical and biological wastes are disposed of according to

local and state regulations. Prepare and submits applicable safety and

environmental reports, application filings, and fees. To include Air

Quality Management, Hazardous Materials Business Plan, and Worker's

Compensation, Hazardous Waste Generator, Community Right to Know, Solid

Waste Reporting, and Medical Waste Management.

Develop and implement occupational health, safety, and environmental

protection programs. To include developing written plans and procedures in

response to laws, regulations, company directives and standards, and site-

specific requirements; this also includes soliciting input from affected

stakeholders and developing and conducting employee training programs, both

classroom or online instruction.

Review and assess facility activities to determine level of

compliance with site-specific procedures, corporate mandates local, state,

and federal regulations; develop documents such as assessments, plans,

policies and procedures to assure all work and activities are performed in

conformance with policies; oversees development and implementation of

corrective action plans as necessary.

Develop effective and positive communications and fosters good

relations with regulatory agencies regarding operations of the facility

relating to safety and environmental issues. Ability to work with the Site

Management Team by providing technical support to initiatives or capital

projects requiring safety or environmental assessments.

Act as a liaison with regulatory agency personnel on site inspections

and permitting issues; these may include waste water or storm water

discharge permits, air quality permits, hazardous materials and fire code

inspections, waste management, and occupational safety and health; acts as

a liaison with suppliers providing safety or environmental related products

or services. Ensure vendors and contactors and suppliers comply with

company standards.

Participate in leading emergency planning and emergency teams.

Respond to emergency situations involving hazardous materials incidents or

spills, confined spaces, first aid etc. Communicates safety issues with

key stakeholders; maintains an open dialog with department leaders on

safety and environmental issues and provides guidance on technical issues.

Facilitate Site Safety Committee and participates in cross-functional

meetings. This also may include preparation and distribution of

newsletters, committee meeting minutes, intranet website, and other

internal communications.

Provides appropriate job-specific ES&H training for site staff;

ability to develop and present needed safety and environmental training and

periodic refresher training. Provide direction and guidance to more junior

S&E staff members. Ability to supervise Facilities and ES&H staff during

special projects or initiatives; participates in emergency planning, and

emergency teams. Responds to emergency situations involving hazardous

materials incidents or spills, confined spaces, first aid etc.

Conducts documented investigations of accidents and injuries.

Monitors and properly documents employee exposures to hazardous materials

and hazardous condition in the workplace. Coordinates site-specific

occupational health monitoring programs; conduct data tracking and

reporting, root cause analysis and trending of injuries, accidents,

incidents and near misses. Develops and maintains ES&H program metrics for

trending and reporting to regulators and management.

Monitor vendor operations, security and safety programs, with processes for

quality and effectiveness personnel efforts; formulate recommendations for

improvement and ensure maintenance programs are administered in compliance

with contract terms and applicable federal and state laws and regulations

and with company policies and procedures. Supervise Facility, EH&S,

Industrial Hygiene, and IT staff and contactors by assigning and directing

work efforts; implement and manage procedures and practices that ensure

quality assurance for work performed by staff and contactors.

. Financial responsibility for Facilities and ES&H Laboratory Operations;

. Develop scope-of-work for facility controls, remote metering,

conservation measures, and the development of preventative maintenance

standards for reduction in energy conservation;

. Ensure regulatory compliance with city, county, and federal regulations

for 67k square foot office and laboratory area;

. Implemented CDC and NIH BioSafety Guidelines for BSL 2+ laboratories;

. Developed and Implement SAP programming for Operations;

. Establishment and implementation of Vivarium, Radiation, Biological, and

Chemical safety programs;

. Created and implemented personnel training programs, to help ensure safe

working conditions;

. Personal training: 40 Hour HAZWOPER certified with hands-on experience in

providing first aid, cardio pulmonary resuscitation, and skilled with the

use of respirators and SCBA systems.

INTERGRATED ENGINEERING SERVICES, Employment contract acquired by Merck &

Co February 2007 to August 2008

Contractor for Facilities Operations, ES&H, Occupational Heath, and

Radiation Safety

chemical, electrical, and mechinical engineering company, santa clara

county, california

In the service of IES, function as the lead administrator for the

improvement of contemporary facilities operations with construction project

management; to plan, direct, coordinate, or budget, usually through

subordinate supervisory personnel, activities concerned with the

construction and maintenance of structures, facilities, and systems.

Participate in the conceptual development of a construction project and

oversee its organization, scheduling, and implementation.

Develop and implement occupational health, safety and environmental

protection programs. This includes developing written plans and procedures

in response to laws, regulations, company directives and Standards, and

site-specific requirements. This also includes soliciting input from

affected stakeholders, and developing and conducting employee trainings.

Perform as a liaison with regulatory agency personnel on site

inspections and permitting issues; to include waste water or storm water

discharge permits, air quality permits, hazardous materials and fire code

inspections, waste management and disposal, with occupational safety and

health. Acts as a liaison with suppliers providing safety and/or

environmental related products or services; ensures suppliers comply with

Company S&E standards.

Coordinate and implement capital planning programs; provide Risk

Management for laboratory and manufacturing clients. Develop and implement

programs on energy policy and conservation, manufacturing space planning,

and equipment preventive maintenance programs. Review and assess facility

activities to determine level of compliance with site-specific procedures,

corporate ES&H mandates, and federal, state and local regulations.

Responsible for environmental and cGMP compliance activities to

include, auditing, reporting, recordkeeping, and training; direct

environmental activities; develop budget proforma, manage environmental

consultants and building contractors, including scheduling, monitoring of

productivity, reviewing consultant performance on a project level, and

providing technical input to project participants.

Intergraded Manufacturing with Facilities policies and procedures to

ensure compliance with federal, state, regional, and local laws for the

reduction of corporate liabilities maintains the quality assurance

programs:

. Assists in specific areas for the development of corporate disaster

programs;

. Ensure clients receive quality service by acting as a consultant and

resource for administration, managers, and staff on matters related to

facilities, environmental management, and industrial hygiene;

. Perform needs assessments; conducts and participates in multi-

disciplinary team conferences, and reviews customer satisfaction reports;

. Act as administrative and Industrial Hygiene liaison for local, state,

and regulatory agency inspections and surveys, including Federal OSHA,

EPA, Cal/OSHA, and the State Fire Marshall;

. Develop, implement, and present professional training programs for the

different regulatory requirements;

. Conduct comprehensive audits of facilities and ES&H programs to identify

areas for improvement;

. Collaboratively develop plan-of-action regulatory programs with

department managers.

. Expand and execute strategies to maintain compliance and constantly

improve stewardship activities.

. Develop training materials; conduct on-site training sessions on

environmental and occupational compliance policies. Present facilities

engineering consulting services to the biotechnology, pharmaceutical

industries

. Provide executive leadership and management of agency operations,

including guidance and direction of agency programs, administration,

financial and budgetary matters;

. Develop and provide crisis analysis and alternatives for decision making;

. Recommend and implement specific action and ensure decisions are

implemented;

. Solid background knowledge of the California legislative process.

. Conduct effective occupational safety, facility inspections, and audits.

Evaluate Industrial Hygiene survey findings, analyze data, and make

appropriate recommendations:

. Apply knowledge of administrative and business processes, personnel

management, and budgetary controls;

. Evaluate financial and human resource management activities to ensure

compliance with state and federal laws, rules, and regulations;

ELAN BIOPHARMACEUTICALS, INCORPORATED

July 2003 to February 2007

Manager Environmental Health & Safety, Occupational Health and Radiation

Safety

research, development, and manufacturing biopharmaceuticals, san mateo

county, california

Ensure integration of facilities management and construction projects with

security and safety program services; plan for repair, maintenance of

laboratory enhancement projects with the assessment of feasibility

forecasts of proposed plans, projects, and equipment.

Monitor vendor safety operations and security programs and processes for

quality and effectiveness; make recommendations for improvement and ensure

maintenance programs are administered in compliance with contract terms and

applicable federal and state laws and regulations, and Elan's policies and

procedures.

Supervise facilities staff and trades by assigning and directing work

effort and safety training; implement and manage procedures and practices

that ensure quality assurance for work performed by facilities and building

staff and outside vendors.

Oversee the functioning, operation, maintenance of laboratory systems

including mechanical, electrical, plumbing, data lines, phone lines, air

conditioning and heating, building structure, fire safety, elevators, etc.

and coordinate repairs with building management. Audit facilities to

assess conditions and take appropriate responsive action to ensure the

quality of the working environments; plan maintenance projects so that they

minimize negative impact on the staff while assuring facilities are

properly maintained, prepared, and appropriate for their intended use;

oversee the purchase of laboratory and facilities related equipment,

supplies, and furnishings.

Facilities and ES&H experience comes with Worker Compensation

compliance, Risk Management, and compliance with the federally mandated

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

regulations; coordinate environmental and safety risks with laboratory

management by developing a Chemical Hygiene Plan and Injury Illness

Prevention Program; ensuring a healthy and a safe work environment by

minimizing or eliminating exposure to occupational hazards.

In support of the Biological Safety Officer and as Chemical Hygiene

Officer responsible for the safe management of chemical and biological

wastes through the administration of disposal programs; experienced in the

negotiation, development, and revision of facility contracts and bids, as

necessary in ensuring all wastes are handled, stored, and shipped in

accordance with state and federal regulatory requirements.

Monitor workers compensation claims and benefits with the coordination

of modified work programs; Implement fire prevention and protection methods

with development and delivery of fire training for employees; Radiation

Safety Officer experience is in the development and management of radiation

safety programs as a licensed radiation worker in the State of California;

expertise in the development of radiation and chemical monitoring policies

for Cal/OSHA.

Management of radiation survey measurements and safety audits of

laboratories and manufacturing sites; writing of safety inspection reports

where radioactive material are used; maintain files related monitoring and

audits; track compliance issues in regard to following-up audits on

surveys; informing and instructing of employees of relevant polices and

acceptable practices.

Directed activities of employees within the following technical

subgroups: radiation safety, chemical and biological health and safety,

occupational health and safety, and emergency response and evacuation;

serves as the technical expert on behalf of the campus in interactions with

local, state and federal regulatory agencies in areas of hazardous

materials develops and maintains financial plan for administration and

management of subgroup health and safety programs.

. Develop scope-of-work for HVAC improvements, digital controls, remote

metering, conservation measures, and development of preventative

maintenance standards for reduction in energy conservation;

. Ensure regulatory compliance with city, county, and federal regulations

for a 150k square foot campus;

. Development of CDC and NIH BioSafety Safety Guidelines for BSL 2+

laboratories;

. Developed new SiteHawk MSDS electronic and paper organization and

retrieval systems;

. Creation and implementation of Radiation, Biological, and Chemical safety

programs;

. Personal training as follows: 40 Hour (HAZWOPER) OSHA1910.120 certified

with hands-on experience in providing first aid, cardio pulmonary

resuscitation, and emergency responds team skilled with the use of

respirator and SCBA emergency systems.

SUGAN at PHARMACIA, INCORPORATED, purchased and closed by Pfizer, Inc.

July 2001 to August 2003

Manager Environmental Health & Safety - Occupational Health and Radiation

Safety

research and development biotechnology and pharmaceutical, san mateo

county, california

In coordination with XL Construction and subcontractors, as part of the

management team, for pre-construction and construction services; complete

laboratory and administrative space for two story South San Francisco

building. To include integration of facilities and ES&H management and

operations with building security and safety plans into services; plan for

repair, maintenance and enhancement of laboratory projects with the

assessment of feasibility forecasts of proposed plans, projects, and

equipment.

Administer the functioning, operation, maintenance of laboratory systems to

include mechanical, electrical, plumbing, data lines, phone lines, air

conditioning and heating, building structure, fire safety, elevators, etc.

and coordinate repairs with building management.

Scheduled audit facilities to assess conditions and take appropriate

responsive action to ensure the quality of the working environments; plan

maintenance projects to minimize negative force on the staff while assuring

facilities are properly maintained, equipped, and appropriate for intended

use; oversee the purchase of laboratory and facilities related equipment,

supplies, and office and cubical furnishings.

Supervise vendor safety operations and security programs and processes for

quality and effectiveness; make recommendations for improvement and ensure

maintenance programs are administered in compliance with contract terms and

applicable federal and state laws and regulations, and Merck policies and

procedures. Supervise facilities staff and trades by assigning and

directing work effort and safety training; implement and manage procedures

and practices that ensure quality assurance for work performed by

facilities and building staff and outside vendors.

Researched, designed, environmental health and safety protection

programs to blend into the physical laboratories; continuation of the

develop health and safety programs in compliance with local, state and

federal reporting and licensing requirements; directed activities of

employees within the following technical subgroups: radiation safety,

chemical and biological health and safety, occupational health and safety,

and emergency response and evacuation.

As ES&H, oversee preliminary site inspections, new laboratory, and

operations expansion; with the review environmental compliance

investigation reports making recommendations to management based on

regulatory compliance regulations.

Directed and administered the preparation and maintenance of mandated

environmental regulatory licenses, records, and permits; developed policies

and procedures regarding use of hazardous materials. Develop, implement,

and administer technical training programs for administrative and research

personnel to ensure compliance with prevalent state and federal

regulations.

Inspect and audit laboratory work facilities and equipment and to

consults with principal investigators on as need basis, and to supervisor

planned experiments and research activities involving the use of hazardous

materials as to meet safety standards; determine if equipment and work

facilities conform to health and safety standards, as facilities consults

with engineering and construction personnel on renovations or new proposed

facilities projects.

. Manage daily operations for multiple programs involving facilities,

staff, and vendors.

. Development of CDC and NIH BioSafety Safety Guidelines for BSL 2+

laboratories;

. Supervised and administered procurement, reception, and distribution of

regulated hazardous materials arriving or departing the campus. Serves

as an expert technical staff resource to the campus and safety

committees, prepares health and safety status reports on current programs

and activities;

. Provided expert technical consultation to campus and principal

investigators regarding appropriate health and safety protection

parameters and safety needs of proposed experiments or procedures;

directed and

. supervised environmental health and safety specialists and technicians

and other staff members to ensure program compliance with applicable

campus and regulatory policies and procedures;

. Serves as the technical expert on behalf of the campus in interactions

with local, state and federal regulatory agencies in areas of hazardous

materials develops and maintains program budget for administration and

management of subgroup health and safety programs;

. Recommend improvement and change of existing health and safety programs

and their application through interaction with professional groups such

as the Health Physics Society, American Industrial Hygiene Association,

American Biological Safety Association, American Chemical Society,

Environmental Protection Agency, and the Department of Environmental

Protection.

PAJARO VALLEY MEDICAL GROUP INCORPORATED

September 1997 to August 2001

Director of Operations, Occupational Health & Practice Management

multi-specialty occupational medical group, santa cruz county, california

Demonstrate experience with the coordination of financial management

of physician management operations to include the implementation and

utilization of sophisticated practice management data bases programs with

the talent to interact effectively with all levels of the organization

which encompass physicians, hospital clinical leadership, and senior

hospital administrators, with the front line nursing staff.

. Administration for (210) physician medical group, General Practice &

Specialty Physicians;

. Negotiated Workers Compensation contract issues and physician services

contracts;

. PPO and EPO Network design, developed to improve healthcare for local

self-insured commerce;

. Developed financial strategies for Integrated HealthCare Delivery System

(IHDS);

. Developed physician's service plan for worker's compensation program a

healthcare product;

. Occupational Health operations towards the growth of an Integrated

Delivery System;

. Evaluate health care services for employee care, for the improvement of

the delivery of health care.

GOOD SAMARITAN HOSPITAL SYSTEM

June 1993 to September 1997

Director Diagnostic Imaging & Radiation Therapy

health dimensions incorporated, hospital management corporation, santa

clara county, california

Administered the planning, design, construction, renovation and

maintenance of existing and new Diagnostic Imaging and Radiation Therapy

facilities and grounds comprising of 100k square feet; supervised a staff

of 172 and monitored and controlled a budget of over $44 million. Over the

term of projects; negotiated, administered and monitored primary

contractors and subcontractors. Improved communications and assured the

harmonization of services between vendors, contractors and hospital

departments.

Through SAP services, controlled equipment and supplies inventory;

recommend purchase, locate, negotiated prices, and order equipment and

supplies for new imaging modalities; maintain vendor contacts and backup

purchase documentation files for reference or reporting, as needed; plan

and developed program objectives and content; research and identify trends

and needs and establish diagnostic imaging directions accordingly; assess

quality of program operations; modify existing program services or create

new program offerings to maintain or enhance program standing; develop

curricula and course materials and coordinate faculty recruitment and

involvement; and link program with other relevant departments on or off

campus as necessary.

PRECISION ACOUSTIC DEVICES INTERNATIONAL

October 1989 to June 1993

General Manager, Advanced Medical Imaging Surgical Devices

medical device research & development and manufacturing, alameda county,

california

Directed aspects of planning, design, construction, renovation and

maintenance of existing and new R&D Defense Advanced Research Project

Agency (DARPA) facilities comprising a total of 65k square feet; supervised

a staff of 89 and monitored and controlled a budget over $32 million;

negotiated, administered and monitored contracts and subcontractors;

Improved communications and assured the coordination of services between

vendors, contractors, and academic departments.

Assessed quality of program operations; modify existing program

services or created new program offerings to maintain or enhanced program

standing; developed curricula and course materials and coordinate research

recruitment and involvement; linked program with other relevant departments

on or off campus as necessary; developed and recommend program operating

and administrative policies; managed the dissemination,

interpretation and application of program policies and recommended approval

of exceptions; managed the delivery of services to targeted program

participants or beneficiaries;

Set and communicate program priorities and performance standards and

assess operations using these criteria; plan and conduct quality assurance

reviews and recommends changes as appropriate; developed and maintain

automated or manual systems and procedures to facilitate program

operations; searched for government funds for program operations;

development of grants to fund programs or work with faculty, researchers

and/or staff to develop research proposals; develop strategies for

marketing or promoting programs to include market research and development

of marketing plans, personal networking, newsletters and publications or

other communications materials, and events planning.

NIDEK INTERNATIONAL

August 1984 to October 1989

Manager, Manufacturing Services and Regulatory Compliance, Surgical

Equipment

medical device and pharmaceutical research & development and manufacturing,

gamagorie, japan

Monitored and co-directed the planning, design, construction,

renovation and maintenance of existing and new R&D and manufacturing

facilities and grounds comprising a total of 64k square feet; supervised a

staff of 36 and monitored and controlled a budget of over $12 million.

Improved communications and assured the coordination of services between

vendors, contractors and university departments.

Ability to interpret and apply international laws, policies and

standard procedures to a diverse array of international patent and

technical issues within the surgical instrumentation advancement; interface

and coordinate with worldwide overseas departments; clearly communicate

ideas and recommendations orally and in writing to a wide spectrum of

European and Asian contacts; effectively presented and transferred

information to establish and maintain cooperative working relations in a

tough multicultural environment.

Responsibility for the timely preparation of product and manufacturing

regulatory submissions with particular emphasis on IDE, and PMA; actively

participate on new product development teams as a representative of

regulatory affairs and deliver guidance and feedback on regulatory pathway

to market, processing changes, and device modifications. Developed written

rationales for advance medical devises, and prepare timely submissions for

such products to the FDA and CDRH.

Review, approve, and authorize document charge orders and product

releases. Prepare regulatory documentation in compliance with specific

requirements including device listings. Guided engineering teams on

various product-testing requirements including functional, biological, and

pharmacological testing protocols to support regulatory submissions as

needed.

Official Correspondent with the FDA regarding company registration,

filings, device listings, compliance, requirements, labeling, and export;

this also includes leading all company efforts toward compliance with

foreign regulatory requirements and to work with Medical Device Safety

Services in Canada and Mexico.

Contribute to the development of and approval of labeling,

promotional, and educational materials; promoted awareness and

understanding of the company's code of Conduct & Privacy and Corporate

Compliance Program initiatives; coordinated, trained, and informed

management of ongoing risk assessments through standardized monitoring and

auditing procedures; developed policy and procedure audits related to

patient well being with corporate international compliance.

COOPERVISION INTERNATIONAL

September 1979 to August 1984

Senior Manager, Corporate Services International, Surgical Equipment

medical device research & development and manufacturing, orange county,

california

Directed aspects of planning, design, construction, renovation and

maintenance of existing and new R&D and service facilities of 55k square

feet; supervised a staff of 12 and monitored and controlled a budget of

over $5 million; negotiated, administered and monitored contracts and

subcontractors. Improved communications and assured the coordination of

services between vendors, contractors and university departments.

Responsible for maintaining regulatory compliance of the Quality

Systems in accordance with FDA requirements; included maintaining a

document control system, identifying and implementing corrective and

preventive actions, improving policies and procedures to maintain

regulatory compliance in a changing product environment, creating and

updating Device History Files and Device Master Records, authoring new PMA

submissions, hosting and conducting regulatory required audits,

As Regulatory Affairs, will work closely with marketing and customer

service personnel to receive design input from healthcare professionals,

develop product design requirements, investigate and resolve customer

complaints, convert product performance data into product marketing

literature, and interface with both FDA and hospital administration staff

on issues of regulatory compliance regarding IRB and JCAHO.

Responsible for identifying the resources required implementing a design

based on those requirements. This includes directing and coordinating the

efforts of other technical contributors associated with product development

and manufacturing, creating and maintaining project schedules, and

providing timely project status reports to the COO. This position requires

skills in mathematics, analysis, strategic planning, negotiation, and

project execution. Responsible for Health & Safety and Occupational Safety

for international service engineers;

UNIVERSITY OF CALIFORNIA IRVINE MEDICAL SCHOOL October

1974 to September 1979

Manager of Research Radiopharmacy, Molecular Nuclear Medicine, with

Radiation Therapy and Ultrasound

In association and financed by the National Institute of Health and Center

for Disease Control

Consult with peers to developed solutions, design, and specifications

to satisfy research needs; expand project schedules and estimate staffing

and additional resource requirements; supervise work of staff to ensure

project plans and schedules are adhered; ensure satisfaction with services

provided; managed daily operations of imaging pharmacy and imaging

laboratory to provide specific technical expertise; direct multifaceted

projects.

Assigned staff; recruit, screen, hire and train staff; evaluate

employee and student performance and provide guidance and feedback to

assigned staff; counsel or discipline employees as required; develop

departmental goals and objectives; implement and communicate to staff goals

and objectives; re-evaluate or redefine priorities as appropriate in order

to achieve performance objectives; participate in development and

documentation of internal operating policies and procedures.

General Safety and Risk Management: responsible for developing and

implementing safety and health policies and training programs to address

respiratory protection, ergonomics, hearing conservation, formaldehyde

handling, chemical hazard awareness, emergency response, performing

facility inspections and program audits to identify safety hazards or

noncompliance with state and federal safety regulations; maintaining and

monitoring employee safety training records. Industrial Hygiene:

responsible for conducting industrial hygiene monitoring and ergonomic

analysis to evaluate employee exposure to chemical and physical agents or

injury producing work practices and provides written results and

recommendations to management.

. Provide leadership, direction, and guidance to staff and student

personnel regarding imaging and radioimmunoassay procedures, techniques,

and use of equipment.

. Develop, plan, and implemented radiation health and laboratory safety

programs with the advancement of imaging specificity for Radiological,

NM, US, and PET imaging modalities.

. Planed, designed, and conducted highly specialized, technical and

unusually complex imaging research projects independently; with

development of molecular tagging programs for advanced imaging

techniques.

. Worked under consultative direction from medical director toward long-

range goals and objectives, exercising considerable latitude in

determining research objectives and approaches; contributed to the

development of advanced concepts, techniques, and standards.

. Analyzed and evaluated research data utilizing scientific computer

systems to provide interpretations requiring significant knowledge of

imaging research.

. R&D for Cardiovascular and Central Nervous System imaging with

functionality assessment;

. Accountable for annual survey and inspection of all radiation producing

machines registration with DHS and license fee payments; managed and

maintained program compliance with State and Federal regulatory agencies.

. Developed solutions to a wide range of research problems of unusual

complexity, which required a high degree of ingenuity, creativity, and

innovativeness; created or modified methods and techniques for obtaining

solutions that were consistent with research objectives.

. Screening tumor and tissue banks/human samples, signal transduction, and

cancer immunotherapy towards developing new surgical, radiation, and

drug treatments with the expansion of clinical trials.

Member Organizations

> Society of Molecular Nuclear Medicine

> American Society of Safety Engineers

> American Biological Safety Association

> Northern California Health Physics Society

> American Industrial Hygiene Association[pic]

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