Responsibilities:

1. Ensure that the Quality Management System (QMS) is effectively implemented and complies with all applicable domestic and international laws, regulations and standards

2. Contribute to managing and improving QMS

3. Support QMS-related actions including but not limited to

 Preparing, reviewing and implementing quality assurance policies and procedures

 Assisting in vendor quality management including planning/performing routine inspections and audits

 Conducting Incident Investigation, Root Cause Analysis, and Impact assessment

 Documenting quality assurance activities and creating/approving audit reports

 Providing/Coordinating specific quality trainings to relevant employees

Qualification requirements:

1. Minimum 3 years of experience in QC and QA activities in the pharmaceutical, biochemical, or food industry

2. Bachelor degree or higher in science related field with laboratory experiences

3. The capacity for new experiences and challenges

4. Willingness to take increasing responsibilities while learning at the job

The ability to commit to the team's mission over individual interests

岗位职责：

1. 独立有效的协助总裁处理综合、协调各部门工作和处理日常事务；

2. 负责总裁个人行程安排的管理；

3. 负责处理、安排并及时提醒总裁参加公司内外各类商务、行政活动；

4. 负责拜访总裁的客户接待安排，客户酒店、用餐、出行等的统筹安排；

5. 协助总裁协调公司内外部工作协调与资源调配，确保项目高效率推动。

岗位要求：

1. 本科及以上学历，985高校毕业，生物医药，管理等相关专业；

2. 2年以上总裁助理工作经验

3. 职业方向比较明确，为人诚信、务实，注重细节，责任心强，执行力强；

4. 英语听说读写熟练，熟练使用办公软件

5. 时间观念强，抗压能力强；

6. 具备优秀的思维逻辑及沟通协调能力、良好的原则性和灵活性；

7. 形象气质良好，熟悉商务礼仪，言谈举止得体。

Primary Responsibilities:

• Provide preclinical safety expertise and strategy for pre-clinical and clinical development programs from pre-clinical drug candidate selection to IND enabling and clinical trials

• Apply a broad understanding of toxicology, pharmacology, DMPK and regulatory sciences to design all types of toxicology studies required to support drug development of biopharmaceuticals

• Ensure that the preclinical safety plan is aligned with the clinical development plan and regulatory guidelines (ICH, FDA, GLP, etc.)

• Serve as Preclinical Safety team leader for multiple programs and contribute to the program’s goals and deliverables

• Identify and manage contract research laboratories (CRO) for preclinical safety studies; review reports; ensure they are using systems and processes in compliance with all relevant regulatory standards

• Write and review documents for INDs / regulatory section submissions; represent the company as the pre-clinical toxicology expert before regulatory authorities

• Serve as a subject matter expert to provide input for due diligence of potential external partnership programs

Qualifications:

• 10+ years of combined toxicology, drug development and regulatory experience in a biotech, biopharmaceutical or CRO setting

• Extensive knowledge and expertise with in vitro and in vivo toxicology study conduct and reporting

• Familiar with applicable regulatory guidelines; prior experience with regulatory agency interactions is preferred

• Proven leadership and management skills, including the ability to interact effectively with CRO personnel and internal/external experts for the conduct of toxicology studies

• Good communication and technical writing skills in English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts

Education:

• Ph.D. or equivalent in Toxicology or closely related field

• Toxicology board certification is a plus