R&D Quality Assurance Specialist(J24811)

1. Independently conduct IND, NDA project audits (e.g., protocols, data, reports, etc.) and facility inspections, identify nonconformities, assess associated compliance risks, and prepare detailed QA audit reports.
2. Manage and oversee quality issues, deviations, and CAPAs, ensuring all actions are effectively and promptly addressed, tracked, and closed.
3. Facilitate discussions with team members and escalate any nonconformities or critical quality issues to laboratory and senior management.
4. Support sponsor audits and regulatory inspections as the primary QA liaison, coordinating between internal stakeholders and external auditors, and ensuring timely and comprehensive responses with follow-up on action items.
5. Review and approve internal SOPs, ensuring alignment with regulatory requirements, and collaborate with the Compliance team to monitor and enhance overall compliance.
6. Oversee and participate in the lifecycle management of computer system validation (CSV) to maintain systems in a validated state throughout their operational lifecycle.
7. Continuously identify and assess potential risk areas, communicate findings to management, and propose and implement risk mitigation strategies.
8. Develop and deliver training programs for internal stakeholders to enhance quality awareness and compliance with quality standards.
9. Collect and analyze the latest regulatory and industry developments, ensuring the company's quality systems remain up-to-date and aligned with current standards.
10. Lead and promote quality improvement initiatives and projects to enhance R&D operational efficiency and overall research quality.
11. Perform additional quality assurance tasks as assigned by management.
12. 独立开展IND, NDA项目审核（例如：研究方案、数据、报告等）以及实验室设施设备检查，识别不符合项，评估相关的合规风险，并编写详细的QA审核报告。
13. 管理和监督质量问题、偏差及纠正和预防措施（CAPA），确保所有行动得到及时有效的处理、跟踪和关闭。
14. 参与并协调团队成员之间的讨论，并将任何不符合项或关键质量问题上报至实验室及高级管理层。
15. 作为质量保证（QA）的主要联络人，支持客户审计及监管机构核查，协调内部各相关方与外部审计员之间的沟通，确保及时全面的响应，并跟进行动项的完成情况。
16. 审核并批准内部标准操作规程（SOP），确保其符合监管要求，并与合规团队合作，监督并提升实验室整体合规性。
17. 监督并参与计算机化系统验证（CSV）生命周期管理，确保系统在整个运行周期内保持验证状态。
18. 持续识别并评估潜在风险区域，与管理层沟通发现并提出改进建议，实施风险缓解策略。
19. 为内部团队并提供培训课程，提高质量意识并确保符合质量标准。
20. 收集并分析最新的法规和行业发展动态，确保质量体系与时俱进并符合当前标准。
21. 主导并推动质量改进项目，提升研发运营效率和整体研究质量。
22. 执行管理层分配的其他质量保证任务。

Qualifications

1. Education: MS or BA in pharmacy, biology, or a related discipline, or an equivalent combination of education, training, and experience.
2. Experience: Minimum of 5 years’ experience in the pharmaceutical or biotechnology industry, preferably in Laboratory Quality Assurance or a related technical role.
3. Knowledge and Skills:

• a) Fluent in English, with ability to coordinate client audits and regulation inspections.
• b) Proven knowledge of drug development processes, R&D laboratory operations, and quality management principles.
• c) Excellent written and verbal communication skills, with the ability to work collaboratively across departments and levels of the organization.
• d) Strong organizational and analytical skills, with a proactive and detail-oriented approach.
• e) Ability to manage multiple priorities effectively while maintaining high quality standards.
• f) Understanding and practical expertise in GxP regulations (GLP etc.) is good to have.

1. 教育背景：药学、生物学或相关学科的硕士或学士学位，或具有等同的教育背景、培训和经验。
2. 工作经验：至少5年的制药或生物技术行业经验，优先考虑具有实验室质量保证（QA）或相关技术职位经验者。
3. 知识与技能：

• a) 具备流利的英文能力，能独立对接国外客户审计，监管机构核查的能力。
• b) 对药物研发流程、研发实验室运营以及质量管理原则的深入了解。
• c) 优秀的书面和口头沟通能力，能够在部门和组织各层级间协作。
• d) 较强的组织能力和分析能力，具有积极主动且注重细节的工作方式。
• e) 能够有效管理多个优先事项，同时保持高质量标准。
• f) 对GxP法规（如GLP等）的理解和实践经验优先考虑。