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PHARMA MANUFACTURING quality By L. Garguilo INNOVATION IN BAYER HEALTHCARE'S QUALITY MANAGEMENT LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 26 she became known as a go-to person for difficult projects. She cites an example from a time at a previous company. A leader was needed to identify and imple- ment biomarkers for a new cancer ther- apy. "This was more than 10 years ago when people just started talking about biomarkers; nobody really knew how to proceed. They looked to me for help. It was all innovation, and very gratifying." Her next step, she jokes, was when Genentech lured her "to the dark side," and a job in quality. "At the beginning, I thought there was a dichotomy between innovation and quality management," she says. She struggled to find how an innovative scientist could become a valu- able quality person, and she even worried she might be on the wrong path. That personal struggle ended up placing her on a career-long path of leadership and advocacy for a new quality management approach. She says a breakthrough occurred for her when she gained quality management responsibility for a large anti-cancer drug. "At first it was a basic quality job, focused primarily on lot release. I could see why some people think quality is not neces- sarily innovative," she says. "Granted, in quality you have essential tasks that are repetitive and require methodical check- ing of details, but I soon realized that is a small portion of what quality manage- ment should be doing." The initial challenge was planning the launch of clinical trials in over 20 coun- tries. While it was tedious strategizing applications and approvals, she says she thought, "Nobody can actually direct us in how to do this. We had to create a way for the first global trial of what became a famous drug." A smaller victory within that project proved just as educational to Lin. "We had discussed cold chain management. The drug had to be transported through various countries, climates, clinics, and system regulations. It seemed every other day we would get a call saying a package was in customs for five days, or the dry ice Pharma West 2014 conference in San Francisco. She defines her adopted profession this way: "Quality management is designing manufacturing processes and control- ling strategies to arrive at product quali- ty. It's also about continuously improving product quality so that not only do you better serve patients, but also you derive more rewards from your R&D; invest- ments." QUALITY MANAGEMENT AS A CRITICAL BUSINESS FUNCTION Lin says her desire to further innovation in the quality management field has been growing for years. Personal experience led her to believe there is a major com- ponent of innovation in quality, equally as vital as in all other areas of drug research, development, and manufactur- ing. Moreover, she has a keen view of quality management as a critical busi- ness function and as a tool to help drive and solve business solutions. Her first position, though, was in her first field of study. "As a research scien- tist specializing in cancer, I always want- ed to go into industry to help develop drugs," she says. Throughout her career he's an avowed "innovative research scientist," so what's she doing in quality manage- ment? "Now more than ever, quality management requires innova- tive thinking that comes from the abil- ity to interpret regulations; creatively solve scientific, technical, and business problems; and challenge the status quo. These types of professionals are in demand. I believe this is the onset of a transition, a positive movement in the pharmaceutical quality world." Lin also believes that if any tenured quality managers haven't already noticed the need for change, their bosses will. "If the top quality leaders in bio- pharmaceutical companies today don't have these qualities, they should learn from somebody who does. Otherwise, CEOs will realize, 'We are behind the eight ball on this,' and look for options." Prior to Bayer HealthCare, Lin worked at a number of pharmaceutical and biotechnology companies. She has a Ph.D. from UC Berkeley in cell and molecular biology, two post-docs from UCLA and UC Berkeley, and an under- graduate degree from Fudan University (Shanghai). I met her at the Outsourced Innovation In Bayer HealthCare's Quality Management L O U I S G A R G U I L O Executive Editor "Innovation" and "pharmaceutical quality management" inhabit the same sentence more often these days. Bayer HealthCare's Director of Quality Assurance for Biologic Product Development in Berkeley, Dr. Claudia Lin, takes pride in that. S @Louis_Garguilo