Helena Champion, MS, MBA
Principal Consultant
DRUG QUALITY ASSURANCE, LLC
P.O. Box 972, Winchester, MA 01890
Phone: (781) 729-2102
Cell: (781) 724-6812
Fax: (781) 729-2102
E-mail: DrugQualityAssurance@gmail.com
Office located near Boston and Cambridge, MA - in Winchester.
Web Page: www.drugqualityassurance.com

SPECIALIST CONSULTING / CONTRACTED OUT DRUG QUALITY ASSURANCE.

Helena Champion, MS, MBA, Principal of Drug Quality Assurance, LLC, has over 25 years of U.S and international experience in pharmaceutical and biotechnology manufacturing and testing.

Prior to forming my consultancy, I was a Quality Assurance Director at Wyeth Biotech External Supply, Wilmington MA, and before that held senior positions at Biogen, Genzyme, Millipore Corporation and Cambridge Isotope Laboratories/Otsuka Pharmaceuticals. Drug Quality Assurance, LLC is associated with other drug development consultancies and is therefore able to offer you the combined expertise of several experts in the field where situations dictate the need for more than a single consultant. We have worked extensively in both the United States as well as Europe (Spain, France, Sweden, U.K., Ireland and Germany).

EXPERIENCE:

I bring you the expertise and professionalism developed over years spent in senior positions with several major US and international pharmaceutical and biotechnology companies. I have wide Quality Assurance, Regulatory Compliance and product development experience in both drug substances and drug products and implementation of the new Pharmaceutical Quality System Q10 Guidance in a practical manner.

My API experience includes small molecule synthesis, cell culture and vaccines. My drug product experience includes oral liquids and tablets, inhaled and parenteral dosage forms, and aseptic processing of biotech drugs and packaging. I provide a practical approach derived from years of GMP and GLP manufacturing and hands on product and process development and analytical chemistry laboratory experience. I am expert on the regulatory requirements for good manufacturing practices for clinical development and commercial drug manufacturing and testing. I provide a dynamic and strategic approach to QA for drug development and commercialization and developing and maintaining Quality Systems.

I have extensive experience performing Quality Audits on drug substance, drug product and medical device manufacturers in the USA and throughout Europe. I led and participated in CMO/vendor qualification audits to support activities for drug development programs.

I also do due diligence work for investors and venture capital groups to evaluate the quality systems and regulatory compliance of drug development companies they may fund. I was a keynote speaker at a dinner during the 29th Annual Cowen Health Care Conference, March 16 - 19, 2009 in Boston, where I gave a talk to investment analysts on recent quality issues at local pharmaceutical companies which impacted timelines for approval of their drugs and hence investment in those companies.

HOW I WORK:

I specialize in quality assurance and quality management for drug development and commercialization and contractor quality support for early stage and small to midsized companies. Drug Quality Assurance LLC offers a flexible range of options. I can handle your immediate needs on a project basis, alternatively I am often retained to undertake Quality requirements on a month to month basis, sometimes for smaller companies this may be a few days a month. This allows such companies to achieve compliance at low cost. I can come in and set up your Quality systems and procedures for you or audit your QA procedures for GMP compliance. Similarly I undertake Quality Audits of suppliers and drug and device manufacturers in the USA and throughout Europe on behalf of international companies.

QUALIFICATIONS:

I have a Masters in Science from the University of Guelph, Guelph, Ontario, Canada, and did my research thesis in development of HPLC methods for separation of peptides. I have a MBA from Northeastern University, Boston, MA. My scientific background is in analytical chemistry, organic synthetic chemistry, protein chemistry, biology, microbiology and biochemistry.

SERVICES INCLUDE ALL ASPECTS OF QUALITY ASSURANCE:

MEMBER:

Parenteral Drug Association (PDA)
American Chemical Society
Chemical Consultants Network
Regulatory Affairs Professional Society.