About the Company An innovative biotechnology firm focused on transforming the treatment of serious musculoskeletal diseases. Industry Pharmaceuticals Type Privately Held Founded 2018 Employees 51-200 Categories Pharmaceuticals Biotechnology Health Care Academic Research Medical Conditions Therapeutics Clinical Care Health International Business Manufacturing Medicine Chemical Products Specialties musculoskeletal rare diseases bone cartilage and muscle About the Role Join our dynamic team as the Senior Director of Quality Assurance, where you will have the opportunity to lead all GxP Quality functions including Quality Assurance, Quality Control, R&D Quality, Document Control, Supplier Quality, and Quality Systems. You will play a pivotal role in shaping the company’s quality vision and ensuring global compliance standards from early development through to commercialization. As a key leader, your extensive expertise in large molecule and aseptic manufacturing, regulatory compliance, and vendor oversight will be crucial. You will drive the creation and optimization of scalable Quality Systems, lead major deviation investigations, and manage cross-functional teams in a fast-paced environment. The ideal candidate will hold a Bachelor’s or Master’s degree in a relevant scientific field, with a minimum of 12 years of industry experience and a strong background in Quality Assurance. You will have a verified track record of developing Quality Systems and experience working with U.S. and international Contract Development and Manufacturing Organizations (CDMOs). In-depth knowledge of GxP regulations is essential. We are looking for a strong leader with exceptional mentoring abilities and problem-solving skills. Bilingual fluency in English and Mandarin is a must. You will also be responsible for leading regulatory inspections, overseeing Quality Agreement negotiations, and managing budgets to optimize costs. This role will require close collaboration with Regulatory Affairs for global submissions and ensuring company readiness for regulatory inspections. If you are passionate about quality and making a difference in the pharmaceutical industry, we encourage you to apply. Hiring Manager Title Chief Technology Officer Travel Percent 20% Functions CEO/President Non-Profit Management Operations General Management Strategy