About BioEthicA
BioEthicA LLC is a global consultancy service specializing in pharmaceutical, biotechnology and biologics quality, compliance, regulatory and organizational development within the life sciences and health authority arenas.
The company was founded on a culture of quality and quality by design philosophy and methodology. The business strives to ensure and deliver the ultimate safeguarding of biologics, drugs, devices and combination products for human consumption from early phase clinical trials to commercialization for the clients we serve.
BioEthicA's ability to provide professional advice and experience, is built on expertise and knowledge gleaned both from the pharmaceutical industry and through regulatory knowledge gained from world health authorities and the U.S. FDA.
BioEthicA understands the business needs of both small startups and large corporate pharmaceutical quality management systems. This maximizes leverage in honing your needs to match your company's growth status.
Being based in the St Louis, MO area, facilitates rapid response from a Midwest, central location. Web based or video conferencing availabilities, utilizing web technology to provide answers, while reducing travel time and cost, can be an option for many clients. Experienced in both domestic and international inspection, the business has the flexibility and knowledge to meet demands of a competitive international market.
The BioEthicA mission is to collaborate and partner with clients to deliver the highest ethical, sustainable and quality driven resources firms rely on for brand integrity. The company centers on leadership and industry best practice ensuring effective and sustainable quality compliance processes. BioEthicA fields of concentration:
- Business Facilitation via risk mitigation to the FDA's Six System Inspection Technique - Engineering and Facilities, Packaging and Labeling Systems, Laboratory, Materials and Supplier Management Systems, Production and Quality Systems
- Quality Management Systems - Good Quality is good business
- Regulatory Compliance and Strategy (Domestic / International)
- Quality Management Organization and Team (Management) Development - Human capital and quality culture
About the Consultant
Tara L. Greene, M.S.
Tara Greene is currently the primary Owner and Principal Consultant at BioEthicA, LLC. Tara has over twenty (20) years' combined background, FDA and industry experience setting her apart from the rest. Tara's expertise spans regulatory arenas from small molecule to parenteral and biotechnology drug products; encompassing markets not limited to CDMO's, API, fill/finish; clinical development and commercial manufacturing; from start-up organizations to large, mature biomanufacturing organizations. Tara has lead her teams, coaching and mentoring key staff, senior and junior, in operations, quality and compliance. She has extensive know-how in site readiness for inspections, data integrity, risk management, risk assessment and loss prevention. Applying Operational Excellence principles to Quality has previously been a mainstay tool used within her commercial scope of work.Tara utilizes her education, proficiency and leadership experiences gained as an ex-FDA consultant in the pharmaceutical world to serve her clients. She considers her greatest strengths, leveraging talent to build cohesive teams, personnel and organizational development to empower employees, and building strategic quality confidence which shapes a strong quality culture in personnel and companies with whom she collaborates.
Tara started her career with a biopharmaceutical start-up, Hematech, LLC (now, SAB Biotherapeutics) ending her 10-year tenure as the Quality Control Manager; Downstream Processing. Recognized as the second employee hired to an increased work-force of nearly 100 employees at her departure, her leadership directly contributed to the success of the organization through the development of the Quality Control Laboratory and collaboration establishing the Quality Assurance and Document Management Control departments.
Tara joined the US FDA and built a respected reputation during her six years as a Pharmaceutical Inspectorate and Drug Specialist with the Kansas City District Office leading inspections directly supporting the district work. Tara conducted complex drug, and biologics inspections. Via her years of experience, she's advanced compliance with the FD&C Act regulation to ensure public safety with efficacious, novel, drug products.
From the FDA she returned to industry holding positions as the Director of Quality Assurance with Gallus Biopharmaceuticals, and later as Site Director of Quality for Patheon Biologics, LLC. In both roles she maintained oversite for the firm's St. Louis, MO and Princeton, NJ facilities. Tara reorganized the quality departments and built a competent, loyal staff of over one-hundred direct and indirect Quality, Regulatory and Quality Control personnel. During this time, she further developed her skills in leadership and the discipline required in a quality organization of excellence.
Tara earned a Bachelor of Science in Animal Sciences and Industry/Veterinary Medicine from Kansas State University in 1999 and went on to earn a Master's of Science in Biomedical Quality Systems from San Diego State University in 2008.