Primary responsibilities include: • Provide leadership, direction and development to the Quality Assurance team • Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards and disciplinary action • Initiate and maintain a Quality Management System (QMS) in support of biologic product manufacturing at ac GMP facility. • Ensure that corporate quality procedures and standards are properly deployed and managed according to the QMS. • Ensure that functional areas of responsibility are staffed, organized, and resourced to fulfil cGMP obligations. • Identify quality improvement opportunities and implement solutions by establishing key performance indicators (KPIs) of quality management, monitoring KPI continuously, and addressing promptly undesirable trends. • Investigate quality issues and review results provided by other departments • Interreact with external regulatory agencies as required, and represent Qisheng quality management during internal and external audits and inspections • Ensure third party suppliers /vendors or business partners are properly qualified and continuously monitored for cGMP compliance (e.g. warehouse, distribution, labeling, etc.) • Support in negotiation of relevant agreements including but not limited to master services agreement (MSA) and quality technical agreement (QTA) for vendors as requested • Work in partnership with other departments /functions to ensure proper support to product launches and achievement of project timelines • Ensure all necessary cGMP /cGxP licenses are obtained to keep the business operational and compliant. • Provide expertise to support therapeutic product registration. Education and skills requirements: • A Bachelor’s degree or above in Biology, Chemistry, Engineering, Pharmacy, or other related scientific disciplines • 15+ years’ experience within pharmaceutical or biotechnology industry. • Experience interfacing / working with regulatory bodies or supporting regulatory submissions • Exceptional understanding of cGMP/cGDP regulations, guidelines and compliance requirements. • Ability to plan, implement and achieve significant complex goals and objectives with flexibility, to work collaboratively and effectively with internal and external teams and to build relationships • Proven leadership skills, people management experience, strong written and verbal communication skills, initiative and follow up skills, experience with leading cross functional teams are all necessary for the role. • Demonstrated exercise of sound judgment, discretion, and business decisions