Jennifer Leny

About Jennifer Leny

I provide quality management, leadership and consulting to regulated and non-regulated industries. As a quality management professional and built on a diverse background, my mission is to take projects from zero to full speed ahead with passion, ingenuity and common sense.PROFESSIONAL EXPERIENCE: With professional experience ranging from research and development, analytical testing, production, downstream processing to clinical trials, I have had the opportunity to work along the side of great scientists, customers and clients working in cutting edge science and on projects that address unmet medical needs, including, but not limited to:• Hereditary angioedema (orphan disease, 1st to market in the EU and 2nd to market in the US using transgenic animals for the manufacturing of API)• Cockayne Syndrome (orphan disease, gene therapy)• Asthma/COPD (combination devices)• Diabetes/weight management (blockbuster drug)• Kidney disease (xenotransplantation, gene editing, CRISPR)• Migraine• Sickle cell anemia• CAR-T therapy• Blood thinner (heparin, API)• Pancreatic deficiency (pancreatin, API)• Genetic analysis IKIGAI: My ikigai is at the crossroads of QUALITY, SCIENCE and COMPLIANCE. THE WHY: My passion for working in the life science industry stems from an early life experience caretaking and medically advocating for a family member with a terminal disease amidst the HIV/AIDS epidemic when few treatment options were available. STRENGTHS: Having served in the pharmaceutical, biopharmaceutical, and medical device industries, my success stems from the ability to forge strong relationships with functionally and culturally diverse groups, mentor and coach, lead teams, develop partnerships and achieve results with limited resources. I enjoy implementing and improving quality systems and processes that are right-sized for organizations.QUALITY STYLE: Collaborative, data and compliance driven, solution oriented LANGUAGES AND INTERNATIONAL EXPERIENCE: English, Spanish (fluent). Have lived in Latin America and Europe; extensive international experience (Europe, South America, Asia, Middle East and Africa).QUALIFICATIONS: Master of Science in Biotechnology (UW Madison), MBA (UMASS Amherst), ASQ CMQ/OE, CQA, CQIA, CHA. Additional coursework in biotechnology techniques, regulatory affairs and clinical trials.• Compliance • Batch record review • Investigations • Deviations • CAPA • Root Cause Analysis • SOP Development • Technical Writing • Auditing • Quality Management • Process Improvement

Experience

1. Adjunct Professor

   M.S. In Biotechnology Program, Uw-Madison

   Jun 2024 — Present · Madison, WI, US

   Coursework development for Quality Assurance and Regulatory Affairs Certificate program. For more information: https://ms-biotech.wisc.edu/qara/

Education

• University of Wisconsin-Madison

  BS, Zoology and BS, Psychology

• University of Massachusetts Amherst

  Master of Business Administration (MBA)

• Cranfield University

  Institute for Clinical Research (Cranfield, Bedfordshire, United Kingdom)

• University of Wisconsin-Madison

  MS, Biotechnology

• Madison Area Technical College

  Extensive coursework, Biotechnology Laboratory Technician Program

• Universidad de Guadalajara

  Spanish Immersion (Fluent)