San Francisco Bay Area
Innovative leader focus on enterprise thinking, value creation and impact to business outcome. Diverse background and experience in Pharmaceutical Quality and Compliance. Extensive knowledge in quality control, GMP compliance audit, health authority inspection, and business interpretation of GMP regulations and requirements for United States, EU, China and Asia Pacific countries. Passionate in promoting GMP convergence, inspection reliance, and data driven, risk based decision-making to maximize patients’ benefit. Promote the use of technology and automation to modernize Pharmaceutical Quality Systems and Processes. Held various leadership positions in United States and Singapore. Spent five years on a parenteral manufacturing startup project. Proven successes in developing cross-functional global teams, managing budgets and trade-offs.
Accountable for the strategy and implementation of quality oversight model for external GMP partners from material suppliers, contract manufacturing & testing organizations, logistic, transportation and warehouse service providers, as well as Quality Assurance personnel at Gilead's global affiliates.
Leading a team of quality professionals and partnering with internal and external manufacturing networks to deliver transformative therapies and to create a healthier world for everyone.
Lead a global organization of over 450 professionals in quality assurance, quality control, regulatory affairs, and contract laboratory testing services.
Lead external relations, policies, and strategies as they relate to key quality and GMP compliance activities, coupled with effective processes and systems to enable real time and predictive compliance intelligence analysis and sharing.
Accountable for the overall GMP compliance audit program in the regions, including effective execution of the program, team development, budget, and stakeholder satisfaction, while ensuring the fulfillment of health authority requirements.
Accountable for all aspects of the Quality Control operations to deliver stable, reliable and compliant performance.
Accountable for the design, build and qualification of the Quality Control laboratories. Provided quality oversight for both Manufacturing and Quality Control facilities, utilities and equipment qualification. Built a high performing Quality Control team with complementary knowledge, skills, and expertise to cover the full scope of Quality Control from startup to routine operations.
Held roles with increasing responsibilities from laboratory analyst to group leader. Led team to conduct microbiological analysis on raw materials, products, environmental monitoring and control. Served as the network microbial expert to solve issues related to microbial contamination and participated in the design of product and process microbial control strategy.