质量合规总监

职责/Responsibilities
l 统筹客户/官方审计全流程管理，包括：审计前的准备（日程沟通，文件准备，风险点识别，热点话题演练），现场审计接待与主持，整改回复及跟进闭环
Oversee full lifecycle management of client/regulatory audits, including: pre-audit preparation (schedule coordination, document compilation, risk identification, hot topic rehearsal), on-site audit reception & hosting, CAPA response and follow-up closure.
l 制定并组织实施内部审计计划，向业务部门提供有洞察力的内审建议，形成正式的审计报告，并负责审计问题整改的后续追踪
Formulate and implement internal audit plans, deliver insightful audit recommendations to business departments, prepare formal audit reports, and follow up on corrective actions for audit findings
l 审计缺陷项系统性分析，识别质量体系持续改进潜在机会点，并向业务部门及管理层反馈输出改进建议
Conduct systematic analysis of audit observations, identify potential CI opportunities in the QMS, and provide improvement recommendations to business departments and senior management
l 审计管理流程的优化及迭代升级：基于公司业务需求，协同业务部门，运用精益理念迭代升级审计工作的方式方法及流程制度。
Optimization and iterative upgrading of audit management processes: Collaborate with business departments to upgrade audit methodologies, practices and systems via Lean principles based on business requirements.
l 完成上级交办的其他工作任务
Fulfill other assignments as directed by management

资质要求/Qualifications:
l 药学相关专业
Pharmaceutical-related major
l 学士学历：10年以上跨国制药企业质量保证（QA）岗位工作经验
硕士学历：8年以上跨国制药企业质量保证（QA）岗位工作经验
博士：2年以上跨国制药企业质量保证（QA）岗位工作经验
Bachelor’s: ≥10 years QA experience in multinational pharma companies
Master’s: ≥8 years QA experience in multinational pharma companies
PhD: ≥2 years QA experience in multinational pharma companies
l 具备客户或官方审计的主导经验
Proven track record of leading client or regulatory audits
l 优秀的英语听说读写能力，及出色的沟通协调能力
Excellent English proficiency (listening, speaking, reading, writing) and strong communication & coordination skills