Gary Barrera

  • Gary Barrera
  • Vice President of Quality
  • Qualification: Masters in Business Administration

About

Gary has over 20 years of experience in global Commercial and Clinical Quality and Operations with increasing level of responsibility at Bayer, Genentech, Boehringer Ingelheim and now Theravance Biopharma.

Gary graduated from UC Berkeley with a Degree in Integrative Biology and Environmental Science in 1996 and a Masters of Business Administration from St. Mary’s College in 2011.

His career began in 1996 in Manufacturing Process Development for Kogenate at Bayer.  Gary moved to Genentech in 1997 to work in most every aspect of Product Production and Quality. During this time, the plant launched 6 different commercial products to market, and was manufacturing up to 40 Commercial and Clinical biological entities.

At Boehringer Ingelheim Gary was hired then promoted to site Quality Head, where he lead a divisional initiative to define and improve Quality Culture, prepared the site for BLA and PAI submission, hosted a perfect FDA inspection and hosted training of 100 FDA inspectors.

Now at Theravance Biopharma, Gary drives Quality strategy, governance, and Quality oversight of operations for commercial and clinical programs through an internal and external vendor network. He has established a Quality Manual, Quality Governance, has led or co-led several Regulatory inspections with no observations that impacted the business.

When not at work, Gary is an avid runner, audiophile, and pet lover.

Biopharmaceutical quality assurance and control

Production of biotechnology products requires comprehensive quality standards and systems that meet global cGMP expectations and are based upon thorough scientific knowledge of the product and process. Professionals knowledgeable in the principles and practice of biopharmaceutical quality management are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry.

The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies, this course will develop the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.