Jennifer S Leny

Madison, WI

Pharmaceuticals

Gilson 2016 - 2018
Quality Control Manager and Six Sigma Black Belt
Scientific Commercialization 2016 - 2018
Management Consultant
Shenzhen Hepalink Pharmaceutical Co., Ltd. 2014 - 2016
Qa Compliance Lead
Toastmasters International 2013 - 2016
Area Director
Leny Quality Consulting 2013 - 2016
Quality Consultant

University of Massachusetts Amherst 2019
Master of Business Administration, Masters Cranfield University 2010 - 2010
University of Wisconsin - Madison
Master of Science, Masters, Biotechnology University of Wisconsin - Madison
Bachelors, Bachelor of Science, Zoology, Psychology Universidad De Guadalajara

Quality Assurance
Gmp
Quality System
Fda
Validation
Quality Management
Leadership
Biotechnology
Quality Auditing
Regulatory Affairs
Sop
Pharmaceutical Industry
Process Improvement
Training
Project Management
Management
Capa
R&D
Glp
Medical Devices
Hplc
Change Control
Cross Functional Team Leadership
Manufacturing
Clinical Trials
Technical Writing
Continuous Improvement
Public Speaking
Regulatory Requirements
Internal Audit
Biopharmaceuticals
Lifesciences
Iso 9000
Compliance
Haccp
21 Cfr Part 11
Gcp
Pharmaceuticals
Spanish
Social Media
Lean Manufacturing
Laboratory
Business Management
Professional Mentoring
Training Delivery
Servant Leadership
Leading Change
Technology Transfer
Iso 13485
Microbiology

English
Spanish
French

Six Sigma Black Belt
Six Sigma Green Belt
Certified Manager of Quality / Organizational Excellence, Certified Haccp Auditor, Certified Quality Auditor, Certified Quality Improvement Associate
Competent Communicator, Competent Leader, Advanced Leader Bronze
Osha 30 Hour Course For General Industry

PHARMING GROUP, N.V
De Forest, WI
2008 to 2012
Quality Manager (North American Operations)
PPD, INC
Middleton, WI
2005 to 2008
PHARMACEUTICAL PRODUCT DEVELOPMENT
HYDRITE CHEMICAL CO
Cottage Grove, WI
2002 to 2005
Facility Regulatory Compliance Coordinator
MILK SPECIALTIES BIOSCIENCE
Madison, WI
2000 to 2001
Quality Specialist
PITW
Madison, WI
1994 to 2000
Product Manager/Owner
HAZELTON LABORATORIES

1994 to 1994
Study Technician
UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
1990 to 1994
Research Assistant

UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
2006
Master of Science in Biotechnology
UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
1994
Bachelor of Science in Zoology and Psychology

PHARMING GROUP, N.V - De Forest, WI

2008 to Jul 2012
Quality Manager (North American Operations)
PPD, INC
Middleton, WI
2005 to 2008
PHARMACEUTICAL PRODUCT DEVELOPMENT
HYDRITE CHEMICAL CO
Cottage Grove, WI
2002 to 2005
Facility Regulatory Compliance Coordinator
MILK SPECIALTIES BIOSCIENCE
Madison, WI
2000 to 2001
Quality Specialist
PITW
Madison, WI
1994 to 2000
Product Manager/Owner
UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
1990 to 1994
Research Assistant

UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
2006
Master of Science in Biotechnology
MADISON AREA TECHNICAL COLLEGE
Madison, WI
2000 to 2002
Continuing Studies in Biotechnology
UNIVERSITY OF WISCONSIN-MADISON
Madison, WI
1994
Bachelor of Science in Zoology and Psychology

quality assurance, quality control, quality management, auditing