QA Manager, Assurance China

The Quality Assurance Manager Greater China is responsible for establishing maintaining and continuously improving the Quality Management System (QMS) across all three Eurofins Assurance business units in the Greater China cluster: Consumer Products Assurance (CPA) Food Assurance (FA) and Healthcare Assurance (HA).

This role serves as the primary point of contact for accreditation bodies (CNAS ANAB IOAS) and scheme owners and ensures compliance with ISO/IEC 17065 ISO/IEC 17021 ISO/IEC 17020 ISO 9001 and all relevant certification scheme requirements. The QA Manager is also responsible for interfacing with Chinese government regulatory entities including CNCA (Certification and Accreditation Administration) and CCAA (China Certification and Accreditation Association) ensuring full regulatory compliance for certification operations in China.

Given the breadth of services (product inspection social compliance audits food safety certification GxP audits sustainability certification GMP process certification) the QA Manager must have strong foundational knowledge in certification body operations and be able to apply quality management principles across diverse technical scopes even where deep subject-matter expertise in every discipline is not feasible.

大中华区质量保证经理负责建立维护和持续改进大中华区集群内欧陆质量认证三个业务单元的质量管理体系QMS消费品认证CPA食品认证FA和医疗保健认证HA

该角色是认可机构CNASANABIOAS和认证体系所有者的主要联系人确保符合ISO/IEC 17065ISO/IEC 17021ISO/IEC 17020ISO 9001及所有相关认证体系要求质量保证经理还负责与中国政府监管实体对接包括CNCA认证认可监督管理委员会和CCAA中国认证认可协会确保中国境内认证业务的全面合规

鉴于服务范围广泛产品检验社会合规审核食品安全认证GxP审计可持续发展认证GMP过程认证质量保证经理必须具备认证机构运营的扞实基础知识并能够将质量管理原则应用于不同的技术范围

Work Content 工作内容

1. Quality Management System (QMS) Governance

Establish implement maintain and continuously improve the integrated QMS covering CPA FA and HA operations in Greater China ensuring compliance with ISO/IEC 17065 ISO/IEC 17021 ISO/IEC 17020 and ISO 9001 requirements.

Manage the quality manual procedures work instructions forms and records across all business units ensuring version control accessibility and consistency.

Develop certification rules for the existing and new programs and ensure compliance with the certification implementation rules for each system within the respective business areas.

Conduct management reviews with senior leadership on a scheduled basis and drive follow-up on improvement actions.

Maintain and update the risk register for certification inspection and audit operations.

1. 质量管理体系QMS治理

建立实施维护和持续改进覆盖大中华区CPAFA和HA业务的综合质量管理体系确保符合ISO/IEC 17065ISO/IEC 17021ISO/IEC 17020和ISO 9001要求

管理质量手册程序作业指导书表格和记录确保版本控制可访问性和一致性

制定现有及新项目的认证规则并确保各业务领域内的每个系统均符合相应的认证实施规则

定期与高层领导开展管理评审推动改进措施的跟踪落实

2. Accreditation & Regulatory Affairs

Serve as the primary liaison with CNAS (China National Accreditation Service for Conformity Assessment) for ISO 17065 and ISO 17021 accreditation cycles including application document submission witness audits annual assessment visits and corrective action management.

Interface with CNCA (Certification and Accreditation Administration) on certification implementation rules and regulatory filings certificate maintenance by the certification body scope extensions and compliance with Chinese regulations governing certification activities.

Maintain awareness of CCAA (China Certification and Accreditation Association) requirements for auditor registration and professional development.

Coordinate with international accreditation bodies (ANAB IOAS UKAS) and scheme owners (GFSI schemes GOTS Textile Exchange GRMA SSCI EXCiPACT etc.) for accreditation/approval maintenance.

Prepare for and manage external assessments surveillance visits and witness audits.

2. 认可与监管事务

作为CNAS认可的主要联系人负责ISO 17065和ISO 17021认可周期资质的申请文件提交见证审核年度评审访问和纠正措施管理

与CNCA对接认证实施规则监管备案认证机构批准证书维护注册范围扩展及中国认证活动法规合规

关注CCAA审核员注册和专业发展要求

与国际认可机构ANABIOASUKAS和体系所有者协调认可/批准的维护

3. Internal Audit & Management Review & Corrective Action Programme

Plan coordinate and execute the annual internal audit programme and management review across all BUs ensuring coverage of all accreditation/certification scheme requirements.

Manage non-conformity tracking root cause analysis corrective actions and verification of effectiveness.

Facilitate office audits and process audits at operational level.

3. 内部审核 管理评审与纠正措施计划

规划协调和执行覆盖所有业务单元的年度内部审核计划

管理不符合项跟踪根本原因分析纠正措施及效果验证

4. Auditor / Inspector Competency Management

Oversee the competency management framework for auditors and inspectors across all BUs including initial qualification ongoing monitoring calibration witness audits and re-qualification.

Ensure compliance with APSCA requirements for social compliance auditors CCAA requirements for food/management system auditors and scheme-specific auditor qualification criteria.

Maintain auditor qualification records and manage the annual training programme.

4. 审核员/检验员能力管理

监督所有业务单元审核员和检验员的能力管理框架包括初始资格认定持续监控校准见证审核和重新资格认定

确保符合APSCACCAA和体系特定的审核员资格要求

5. Impartiality & Ethics Management

Ensure the integrity of impartiality policies and conflict of interest management across all certification inspection and audit activities.

Support the impartiality committee operations where applicable.

Manage ethics reporting mechanisms and investigate complaints related to impartiality.

5. 公正性与道德管理

确保所有认证检验和审核活动的公正性政策和利益冲突管理的完整性

6. Complaints Appeals & Incidents

Manage the complaints and appeals handling process in accordance with accreditation and scheme requirements.

Coordinate incident reporting to scheme owners and accreditation bodies when required.

Ensure timely resolution and documentation of all quality-related complaints.

6. 投诉申诉与事件管理

管理投诉和申诉处理流程确保符合认可和体系要求

必要时向体系所有者和认可机构协调事件报告

7. Continuous Improvement & KPI Reporting

Define monitor and report quality KPIs (e.g. NC rates CAPA closure times accreditation findings customer satisfaction scores auditor calibration results).

Drive continuous improvement initiatives across BUs and benchmark against global Eurofins Assurance quality standards.

Participate in global quality meetings and align with corporate quality policies.

Monitor the entire certification process identify gaps and deviations in the process and propose corrective and optimization measures; manage risks by identifying operational certification impartiality and compliance risks and conduct regular risk assessments.

7. 持续改进与KPI报告

定义监控和报告质量KPI如不符合项率CAPA关闭时间认可发现客户满意度审核员校准结果

推动跨BU的持续改进计划参与全球质量会议

认证全过程监督识别认证过程漏洞流程偏差提出整改优化要求风险控制识别经营认证公正性业务合规风险定期开展风险评估

8. Additional Duties 其他职责

Perform other tasks as assigned by the Cluster Manager to support business objectives.

1. 完成集群经理分配的其他任务以支持业务目标

Qualifications :

Education 学历

Bachelors degree or above in Food Science Pharmaceutical Science Quality Management Engineering Chemistry Biology or a related field. Masters degree is a plus.

食品科学药学质量管理工程化学生物学或相关专业本科及以上学历硕士学位优先

Essential Experience 必要经验

Minimum 8 years of experience in quality management within the TIC (Testing Inspection Certification) industry or conformity assessment sector.

Minimum 3 years of experience specifically in certification body quality management with direct responsibility for accreditation maintenance.

Proven track record of managing CNAS accreditation processes (application assessment witness audits corrective actions) for certification bodies in China.

Demonstrated experience interfacing with CNCA for regulatory compliance related to certification body operations in China.

Experience managing internal audit programmes and corrective action processes for multi-scheme certification bodies.

至少8年TIC检测检验认证行业或合格评定领域的质量管理经验

至少3年认证机构质量管理经验直接负责认可维护

具有管理CNAS认可流程申请评审见证审核纠正措施的记录

具有与CNCA对接监管合规的经验

Preferred Experience 优先经验

Experience with food safety certification schemes (BRCGS IFS FSSC 22000 SQF) quality management.

Experience with GxP audit quality management (pharmaceutical / healthcare sector).

Experience managing ISO/IEC 17020 accreditation for inspection bodies.

Experience with APSCA membership requirements and social compliance audit quality management.

Experience with IOAS accreditation for sustainability standards (GOTS Textile Exchange).

Experience with ANAB accreditation for ISO/IEC 17065 product certification.

Experience of ISO/IEC 17029:2019 (General requirements for validation and verification bodies).

Experience with CNAS-SV01 (Accreditation scheme for GHG validation and verification bodies) or ISO 14065.

Experience in preparing for or managing CNAS accreditation assessments for verification bodies 

食品安全认证体系BRCGSIFSFSSC 22000SQF质量管理经验

GxP审计质量管理经验制药/医疗保健行业

ISO/IEC 17020检验机构认可管理经验

APSCA会员资格要求和社会合规审核质量管理经验

了解ISO/IEC 17029:2019审定与核查机构通用要求

熟悉CNAS-SV01温室气体审定与核查机构认可方案或ISO 14065

具有准备或者管理CNAS核查机构认可评审的经验

Skills & Qualifications 技能与资质

1. ISO 9001 Lead Auditor certification (highly preffered). ISO 9001主任审核员证书强烈优先
2. ISO/IEC 17065 or ISO/IEC 17021 Lead Auditor certification (highly preffered).). ISO/IEC 17065或ISO/IEC 17021主任审核员证书强烈优先
3. ISO/IEC 17020 knowledge (highly preferred). ISO/IEC 17020知识强烈优先
4. CCAA registered auditor status is a strong plus. CCAA注册审核员资格为强烈加分项
5. Excellent knowledge of Chinese certification and accreditation regulatory framework. 熟悉中国认证认可监管体系
6. Familiarity with ISO/IEC 17029 and CNAS-SV01 is a plus. 熟悉ISO/IEC 17029和CNAS-SV01为加分项
7. Strong document control and process management abilities. 较强的文件控制和流程管理能力
8. Excellent analytical skills and attention to detail. 优秀的分析能力和对细节的关注
9. Strong communication and stakeholder management skills. 较强的沟通和利益相关者管理能力
10. Fluency in Mandarin (required) and proficient English (written and oral). 流利的普通话必须和熟练的英语书面和口语
11. Willingness to travel within Greater China (approximately 20-30%). 愿意在大中华区出差约20-30%
12. Honest responsible and committed to professional integrity. 诚实负责具有职业操守

Additional Information :

Eurofins Company 欧陆公司

Eurofins Consumer Product Assurance (CPA) Food Assurance (FA) and Healthcare Assurance (HA) BUs are three Business Units of Eurofins Assurance under Eurofins Scientific. The Group believes it is a scientific leader in food environment pharmaceutical and cosmetics products testing and in AgroSciences CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics discovery pharmacology forensics CDMO advanced material sciences and for supporting clinical studies. 

Eurofins 欧陆消费品认证(CPA) 食品认证(FA)及医疗保健认证(HA)事业部是Eurofins欧陆科学集团下欧陆质量认证公司的三个事业部Eurofins欧陆集团相信它在食品环境制药和化妆品测试以及农业科学的CRO服务方面处于领先地位在基因组学发现药理学法医学CDMO高级材料科学和支持临床研究等方面的测试和实验室服务方面它也是全球独立市场的领导者之一

Website 网站

Remote Work :

No

Employment Type :

Full-time