職位描述
·？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、負責組建康弘生物北京新廠的質量運行團隊 (QA/QC/VAL)；
2、負責康弘生物北京新廠項目相關質量體系的建立和文件的審批；
3、負責質量運行部門的日常工作管理和監督以及確保臨床前、臨床和商業化生產符合適用的法律法規；
4、協助建立和完善質量管理體系并定期對其適應性和有效性進行評估；
5、負責建立和完善自檢流程，指導、監督和參與內部審計及接待客戶或官方審計；
6、通過回顧質量項目文件、KPI、風險評估和質量計劃等來支持并監督質量管理體系的實施；
7、負責審核并批準關鍵質量文件；
8、負責通報公司高級管理層所有可能會對產品質量發生副作用的重大質量問題；
9、負責為GMP項目提供支持和專業意見，如：技術轉移、GMP設備項目和新產品的上市；
10、在質量部門推動和維持一個良好的團隊間溝通；指導部門經理和團隊負責人并根據需求向相關員工提供培訓；
11、代表質量運行和其他部門合作, 推動公司各項目進展；
12、負責和集團質量管理團隊戰略性的溝通與交流。
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、生物醫藥或相關專業碩士以上學歷，或有同等的工作經驗；
2、15年以上生物醫藥或相關企業工作經驗，10年以上質量部門管理崗位經驗；
3、熟悉國內外GMP、GLP、GCP、ICH和PIC/S等法規／指南要求；
4、熟悉藥品無菌生產、模擬灌裝及環境監測要求；
5、熟悉GMP實驗室的日常管理；熟悉實驗室產品檢驗OOS／OOT／OOE調查的處理原則；熟悉產品檢驗及環境監測微生物的OOS調查的處理原則；
6、具有良好的團隊管理能力和較強組織能力，善于溝通; 具備團隊協作精神、職業道德和工作責任感；
7、熟悉廠房，系統，設備，儀器確認／驗證，計算機化系統驗證，工藝驗證， 清潔驗證，Part 11 法規符合性要求。
