Summary: The Product Quality Leader serves as a technical quality expert for the product during clinical development all the way through post-commercialization and is responsible for making quality-related decisions and serving as a liaison between the project team and other quality functions. This role is the single point of contact for all quality issues associated with the development of one or more early/late phase programs. This role is a key member of the CMC subteam, providing efficient and effective strategic and quality input into CMC related activities and associated quality decisions. *This role is Remote US based Principal Responsibilities: • Quality single point of contact in the CMC team • Lead the creation of product specific quality strategy by working across Quality, Technical Development, Manufacturing and CMC Regulatory groups • Lead Quality Operation team to implement the quality strategy, influence, advice and coordinate strategic and operational efforts across Quality • Drive product quality risk management, issue identification, resolution and contingency planning • Responsible for establishing a phase appropriate Quality Target Product Profile (QTPP) & accountable for ensuring the right quality characteristics are implemented • Responsible for developing a phase appropriate product specification • Author, review, and own the PQ risk register: identify, communicate, elevate, and document acceptance of risk • Stay abreast of changes in regulatory standards and expectations as pertaining to product quality • Author and review CMC regulatory dossier sections and information requests (IND, IMPD) • Advance operational excellence within Product Quality Required Qualifications: • Full professional proficiency in Chinese Mandarin • Principal Scientist level – Requires a minimum of 10+ years experience in pharmaceuticals, biologics, or bio-pharmaceuticals, with experience in a quality related role or a product development role • Associate Director level – Requires a minimum of 16+ years of experience in small molecules or biologics with 10+ years of experience in a quality related role or a product development role with responsibility for life-cycle management of commercial product • 4+ years direct or indirect team management/leadership (i.e. direct reports or matrixed team leadership) • Technical aptitude and experience in therapeutic drug development, analytical, process or formulation development or product characterization • Skilled at guiding technically-oriented business objectives within the framework of regulatory guidance and company quality systems, internally and externally, to achieve value-adding outcomes • Has a bias for action and displays a sense of urgency. Must possess strong skills in leadership and communication • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior team member and to engage and influence team members in a matrixed environment Education: • BS or equivalent in Chemistry, Biology, or a similar life science. Advanced degree is a plus