•Company start-ups, mergers, acquisitions, and integrations.•Corporate Strategies•Regulatory & Clinical Strategies•Operations planning and start-up•Design and implement QMS; GMP, QSR, GLP, GTP (HCT/P), ISO 13485, CLIA/CAP, and ICH.•Corporate representative to global regulatory agencies, customers, suppliers, media, and industry conferences.•IND, IDE, and PMA eCTD submissions.•Product Development Lifecycle•Clinical, industrial, and environmental microbiology.

Provide Quality, Regulatory, and Operations support for start-up Biologics, Pharmaceutical, Medical Device, and Laboratory companies, and remediation support for established FDA regulated organizations.

Start-up biologic/drug and medical device company processing human autologous cell-products for injection, and cell suspension delivery devices.• Maintained and improved quality management system to ensure regulatory compliance with GMP, GTP, QSR, GLP, and ISO 13485.• Responsible for quality assurance, quality control, quality engineering, document and records control departments, and training program.• Responsible for operations planning including, but not limited to: budgeting, purchasing, and staffing to initiate Phase II and III clinical studies in USA.• Served on executive management team that developed strategic business plan to take product from clinical research to commercial including, but not limited to: cost and business models, budgeting, regulatory and clinical strategies, and market research.• Developed and validated rapid sterility test method accepted by FDA for cell-product approval for injection.• Selected and validated rapid mycoplasma test method accepted by FDA for cell-product approval.• Wrote sections and reviewed entirety of IND eCTD submission for Phase II clinical study.• Reviewed and approved Phase I and II clinical study reports prepared by CRO.• Ensured FDA annual report on-time reporting by standardizing interdepartmental data collection and timelines.• Wrote sections and approved entirety of Phase II clinical study protocols and supporting documents.• Reduced bioburden test cost 90% per lot by validating in-house test method.• Created process metrics resulting in a reduction of reagent turnaround time by 10 days.• Saved $1,804 per product lot by eliminating FDA mandated mycoplasma PTC test by writing and submitting an IND amendment; saving $2,200,000 during ongoing Phase II clinical studies, and $11,000,000 for first year commercialization.• Served as primary contact for regulatory authorities and standards bodies.

Start-up biologic/drug and medical device company processing human autologous cell-products for injection, and cell suspension delivery devices.• Designed and implemented quality management system for all company facilities to ensure regulatory compliance with GMP, GTP, QSR, GLP, and ISO 13485 including, but not limited to: document, record and sample control systems; metrology program; training system; and material and supplier programs.• Responsible for operations planning including, but not limited to: budgeting, purchasing and staffing to initiate Phase I clinical study.• Served on executive management team that developed strategic business plan to take product from feasibility to commercial including, but not limited to: cost and business models, budgeting, regulatory and clinical strategies, and market research.• Presented pre-clinical and operational plans to FDA at pre-IND meeting.• Wrote sections and reviewed entirety of IND submission for Phase I clinical study.• Selected and qualified/validated Marietta manufacturing facility, equipment, processes, computer systems, test methods, and personnel.• Selected non-clinical research facilities to conduct GLP studies.• Researched contract manufacturing organizations to manufacture cell-product; determined manufacturing to remain at ARI.• Investigated feasibility of conducting Phase I clinical study in USA or Britain; selected Scotland facility and transferred technology.• Wrote sections and approved entirety of Phase I clinical study protocol and supporting documents.• Acted as primary contact for regulatory authorities and standards bodies.

Start-up biologic/drug and medical device company processing human autologous cell-products for injection, and cell suspension delivery devices.• Developed and implemented GLP program for research and development departments including, but not limited to: document and record control systems, metrology program, and training scientists.• Served on executive management team that developed strategic business plan to move product from concept to commercial including, but not limited to: cost and business models, budgeting, regulatory and clinical strategies, and market research.

An in-vitro diagnostic and research use only manufacturer of nucleic acid diagnostic test systems for genotyping of infectious agents and human markers.• Maintained a global quality system across United States, Canadian, and European operations.• Responsible for reagent product quality. • Successfully transferred technology from Georgia to Massachusetts.• Served as team member to close Georgia facility.• Functioned as liaison for world regulatory inspection visits for all facilities.

An in-vitro diagnostic and research use only manufacturer of nucleic acid diagnostic test systems for genotyping of infectious agents and human markers.• Maintained a global quality system across United States, Canadian, and European operations.• Directed document and record control personnel.• Managed internal and supplier audits across all facilities.• Conducted corporate quality training for all facilities.• Coordinated corporate validation program.• Responsible for reagent product quality. • Functioned as liaison for world regulatory inspection visits for all facilities.• Successfully transferred reagent manufacturing operation from Pennsylvania to Georgia.• Passed GMed inspection by preparing Visible Genetics Europe for ISO 9002 (ISO 13488) and in-vitro diagnostic medical device directive (IVDD (98/79/EC) inspection for product CE Marking.• Defended patent infringement suit.

Start-up international full service central laboratory specializing in pharmacogenomics test methods supporting clinical trial research for the pharmaceutical industry.• Designed, implemented, and maintained quality system for all facilities to ensure compliance with CLIA, GLP, CAP, and ICH requirements.• Responsible for development and validation of new genotyping-phenotyping test methods in the pharmacogenomics laboratory.• Liaison for regulatory inspections and customer audits.

International full service central laboratory supporting clinical trial research for the pharmaceutical, medical device, food, and biotechnology industries across 5 continents.• Designed and deployed global quality management system founded on ISO 9001 to ensure compliance with state, federal, and international regulations and standards, such as 42 CFR 493, 21 CFR 58, 21 CFR 820, CAP, and ICH including, but not limited to: document control, equipment and method validations, training program, harmonizing methods across facilities.• Developed OSHA compliance program.• Served as liaison for regulatory inspections and customer audits.

Start-up Class III medical device and biologic company processing human cardiac, vascular, and orthopedic tissues for transplant.• Implemented and maintained quality program ensuring regulatory compliance.• Served as primary interface with regulatory agencies, tissue donor families, tissue recipients, transplant medical staff, organ/tissue procurement organizations, and media.• Reviewed product history records, such as tissue donor medical and social history records, tissue retrieval records, tissue processing and quality control records, and infectious disease serology test records to ensure safety of tissue donor and processed tissue product for transplantation.• Wrote sections and reviewed entirety of IDE and PMA submissions.• Responsible for corresponding with FDA regarding intended regulations.

Start-up pharmaceutical manufacture.• Directed and scheduled daily microbiology department tests/activities, including but not limited to: LAL, sterility, environmental monitoring, particulate, and organism identification.• Interdepartmental team for product development.

In-vitro diagnostic (IVD) manufacture of microbiological products used in the detection, isolation, and identification of microorganisms in medical, veterinarian, and industrial applications.• Integrated operations of 3 merged companies into single location and system.• Responsible for quality assurance, quality control, technical services, metrology, and product quality.• Served as primary interface for regulatory inspections.• Acted as Plant Operations Director for 2 years.

Full service clinical microbiology laboratory.• Performed detection, isolation, and identification methods for bacteriology, mycobacteriology, mycology, parasitology, and virology patient specimens.• Designed and implemented media and reagent quality control system compliant with CAP requirements.• Developed weekend and holiday rotation schedule.