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(fù)責(zé)組建康弘生物北京新廠的質(zhì)量運(yùn)行團(tuán)隊(duì) (QA/QC/VAL)；
2、負(fù)責(zé)康弘生物北京新廠項(xiàng)目相關(guān)質(zhì)量體系的建立和文件的審批；
3、負(fù)責(zé)質(zhì)量運(yùn)行部門的日常工作管理和監(jiān)督以及確保臨床前、臨床和商業(yè)化生產(chǎn)符合適用的法律法規(guī)；
4、協(xié)助建立和完善質(zhì)量管理體系并定期對其適應(yīng)性和有效性進(jìn)行評(píng)估；
5、負(fù)責(zé)建立和完善自檢流程，指導(dǎo)、監(jiān)督和參與內(nèi)部審計(jì)及接待客戶或官方審計(jì)；
6、通過回顧質(zhì)量項(xiàng)目文件、KPI、風(fēng)險(xiǎn)評(píng)估和質(zhì)量計(jì)劃等來支持并監(jiān)督質(zhì)量管理體系的實(shí)施；
7、負(fù)責(zé)審核并批準(zhǔn)關(guān)鍵質(zhì)量文件；
8、負(fù)責(zé)通報(bào)公司高級(jí)管理層所有可能會(huì)對產(chǎn)品質(zhì)量發(fā)生副作用的重大質(zhì)量問題；
9、負(fù)責(zé)為GMP項(xiàng)目提供支持和專業(yè)意見，如：技術(shù)轉(zhuǎn)移、GMP設(shè)備項(xiàng)目和新產(chǎn)品的上市；
10、在質(zhì)量部門推動(dòng)和維持一個(gè)良好的團(tuán)隊(duì)間溝通；指導(dǎo)部門經(jīng)理和團(tuán)隊(duì)負(fù)責(zé)人并根據(jù)需求向相關(guān)員工提供培訓(xùn)；
11、代表質(zhì)量運(yùn)行和其他部門合作, 推動(dòng)公司各項(xiàng)目進(jìn)展；
12、負(fù)責(zé)和集團(tuán)質(zhì)量管理團(tuán)隊(duì)?wèi)?zhàn)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(yī)藥或相關(guān)專業(yè)碩士以上學(xué)歷，或有同等的工作經(jīng)驗(yàn)；
2、15年以上生物醫(yī)藥或相關(guān)企業(yè)工作經(jīng)驗(yàn)，10年以上質(zhì)量部門管理崗位經(jīng)驗(yàn)；
3、熟悉國內(nèi)外GMP、GLP、GCP、ICH和PIC/S等法規(guī)／指南要求；
4、熟悉藥品無菌生產(chǎn)、模擬灌裝及環(huán)境監(jiān)測要求；
5、熟悉GMP實(shí)驗(yàn)室的日常管理；熟悉實(shí)驗(yàn)室產(chǎn)品檢驗(yàn)OOS／OOT／OOE調(diào)查的處理原則；熟悉產(chǎn)品檢驗(yàn)及環(huán)境監(jiān)測微生物的OOS調(diào)查的處理原則；
6、具有良好的團(tuán)隊(duì)管理能力和較強(qiáng)組織能力，善于溝通; 具備團(tuán)隊(duì)協(xié)作精神、職業(yè)道德和工作責(zé)任感；
7、熟悉廠房，系統(tǒng)，設(shè)備，儀器確認(rèn)／驗(yàn)證，計(jì)算機(jī)化系統(tǒng)驗(yàn)證，工藝驗(yàn)證， 清潔驗(yàn)證，Part 11 法規(guī)符合性要求。
