职位描述
·？Responsible for leading and managing Beijing Kanghong Biopharma’s quality system improvement initiative across all departments and functions to ensure that quality initiatives and quality plans are executed and maintained in full compliance with cGMP Quality requirements. This includes addressing issues from quality management oversight and helping the site management team to execute effective leadership of quality management enhancement activities.
·？Ensure an effective review on suitability and effectiveness of quality system at defined intervals.
·？Direct and support the resolution of quality problems in the facility activities so that they are consistent industry and company quality standards.
·？Support and supervise quality governance through review of project documents, KPIs, risk assessments, and quality plans.
·？Identify and support continuous improvement projects in collaboration with site management team with objective of achieving quality, reliability and cost improvements.
·？Attend preparation and execution of internal, external and regulatory audits on the site.
·？Participate in or manage quality assessments related to introduction of new products into the facility.
·？Review and approve high level quality documents
·？Ensure that coordinated contact is maintained with other functions, including sharing of better practice and procedures.
·？Ensure that company executive leadership team is well kept informed of all critical and major quality issues which may have an adverse effect on the product quality.
·？Perform review of compliance performance at department and individual level and propose corrective actions.
·？Provide coaching and direction for QA managers and team leaders, and provide training to relevant staff, as requested.
·？Anticipate risks associated with product quality and regulatory compliance, through the prevention and reduction plans, including managing quality and product alerts.
·？Provide quality support and expertise in the GMP projects such as tech transfers, GMP facility projects, and the launch of new products.
·？Provide support to sites as part of the regulatory inspections and external audits.
·？Contribute significantly to the development of best practice within the scope of GMP compliance and regulatory requirements; facilitate interaction and exchange of best practices with other departments and functional areas cross Kanghong Biopharmaceuticals.
·？Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality culture.
·？Representing the quality team, works closely with the heads of other line operations.
·？Take strategic and leadership responsibilities in bridging between the site and the corporate quality management team.
1、负责组建康弘生物北京新厂的质量运行团队 (QA/QC/VAL)；
2、负责康弘生物北京新厂项目相关质量体系的建立和文件的审批；
3、负责质量运行部门的日常工作管理和监督以及确保临床前、临床和商业化生产符合适用的法律法规；
4、协助建立和完善质量管理体系并定期对其适应性和有效性进行评估；
5、负责建立和完善自检流程，指导、监督和参与内部审计及接待客户或官方审计；
6、通过回顾质量项目文件、KPI、风险评估和质量计划等来支持并监督质量管理体系的实施；
7、负责审核并批准关键质量文件；
8、负责通报公司高级管理层所有可能会对产品质量发生副作用的重大质量问题；
9、负责为GMP项目提供支持和专业意见，如：技术转移、GMP设备项目和新产品的上市；
10、在质量部门推动和维持一个良好的团队间沟通；指导部门经理和团队负责人并根据需求向相关员工提供培训；
11、代表质量运行和其他部门合作, 推动公司各项目进展；
12、负责和集团质量管理团队战略性的沟通与交流。
Experience and Knowledge:
·？Expert in quality system implementation & improvement, which include but are not limited to Product Release & Production Batch Record, SOP, Training, External & Internal Audit, Regulatory Inspection, Change Control, Data Integrity, Customer Complaint Management, Qualification & Validation, Technology Transfer (Manufacturing Process & Analytical Method), Deviation and OOS Investigation, Quality Risk Management, External Supplier/Vendor Quality System, Quality Agreement, Quality Metrics, and CAPA Management for Non-conformance.
·？Demonstrated leadership & experience in staff performance appraisal and skill development.
·？Experience in transverse management without direct hierarchical authority or supervision.
·？Having working experience in multinational or oversea company is preferable.
Key Competencies Required:
·？Results orientated
·？Demonstrated ability to achieve results and manage others to achieve corporate, site and functional objective
？ ·Ability to integrate the constraints of each function and identify good solutions while within compliance of regulation
？ ·Team performance complemented by development of skills and performance of individual team members
·？Strong leadership
？ ·Strategy development and execution
？ ·Combined strategic and operational thinking
？ ·Focus on goals with sound judgment
？ ·Ability to manage multiple priorities and act with a sense of urgency
？ ·Pro-active and creative by designing new processes and implementation of those to promote process improvement continuously
·？Communication Skill
？ ·Ability to work in highly diversified cultures
？ ·Ability to work in a matrix, multicultural environment
·？People management and development Skill
？ ·Collaborates and communicates
？ ·Leads others to work together
？ ·Develops team capabilities and staff performance
？ ·Rewards and recognizes desired performance
？ ·Driven by building interpersonal and a proven team builder
1、生物医药或相关专业硕士以上学历，或有同等的工作经验；
2、15年以上生物医药或相关企业工作经验，10年以上质量部门管理岗位经验；
3、熟悉国内外GMP、GLP、GCP、ICH和PIC/S等法规／指南要求；
4、熟悉药品无菌生产、模拟灌装及环境监测要求；
5、熟悉GMP实验室的日常管理；熟悉实验室产品检验OOS／OOT／OOE调查的处理原则；熟悉产品检验及环境监测微生物的OOS调查的处理原则；
6、具有良好的团队管理能力和较强组织能力，善于沟通; 具备团队协作精神、职业道德和工作责任感；
7、熟悉厂房，系统，设备，仪器确认／验证，计算机化系统验证，工艺验证， 清洁验证，Part 11 法规符合性要求。
