Associate Director, HGR Excellence

Typical Accountabilities

• Accountable for HGR process excellence and HGR risks oversight cross functions, including but not limited to process optimization and training, due diligence, global Initiatives, governance oversight, audit and Inspection readiness, to ensure all HGR activities/process are strictly following related HGR regulations.
• Accountable for China HGR overall compliance oversight to ensure all required HGR related activities are properly delivered and therefore support successful clinical trial deliveries in China.
• Lead communication and alignment with R&D China, Science Units and other counterpart relevant China/global functions on related HGR topics.
• Responsible for building up strong engagement and collaboration with external authority and industry, contributing industry infrastructure development.
• As process owner, lead the development and update of SOP, working process, supporting tools and reference.
• Lead development of HGR information management system and ensure it could support oversight and inspection readiness.
• Optimize internal training and knowledge sharing system, ensure timely information and experience sharing within cross team. Ensure regular refreshing training is conducted and training records related to are well kept.
• Lead HGR inspection and internal auditing readiness and oversee assigned activities to be completed.
• Responsible for leading full cycle of HGR related sample and data management, oversight of HGR activities at study level.

Education, Qualifications, Skills and Experience
Essential

• Bachelor degree in healthcare-related field, or equivalent.
• At least 12 years experience in Clinical Operations, including 8 years experience in HGR Management.
• Significant knowledge and experience in HGR inspections and deep understanding of China HGR regulation.
• Strong ability to continuedly optimize HGR relevant process and tools for cross functions, especially for R&D.
• Demonstrate ability to look for and champion more efficient and effective methods/processes of delivering clinical trials with high HGR compliance.
• Excellent communication and cross functional collaboration skills.
• Strong learning agility.
• Risk and crisis management skills.
• Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
• Fluent spoken and written English.

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. 阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.