作为项目QAFL leader，负责项目中质量问题的跟踪和处理，和客户QA对接
As project QAFL leader, follow up quality related issues during project and communicate with client QA
教育程度Education background
Bachelor's degree or above in a relevant field (e.g., Pharmacy, Chemistry, Biology, or Quality Management) or equivalent work experience. Oversea degree is preferred.
经验 Experience
Minimum of 10 years of experience in a quality or manufacturing position in pharmaceutical industry. At least 3 years leadership role.
Familiar with domestic and international regulations, e.g. FDA, EMA, NMPA GMP, including clinical and/or commercial supply
Strong problem-solving and analytical skills, with the ability to identify root causes of issues and develop effective solutions.
Excellent communication skills, both written and verbal, with the ability to effectively interact with clients, team members, and cross-functional stakeholders at all levels.s


Team Leadership and Management:
Lead, mentor, and develop a team of QA professionals, providing guidance, support, and training to enhance their skills and performance.
Set clear goals and expectations for the team, ensuring alignment with the company's overall objectives.
Conduct regular performance evaluations and provide constructive feedback to team members.
Foster a positive and collaborative team environment that encourages innovation, continuous improvement, and high-quality work.


Client Communication:
Serve as the primary point of contact for clients regarding QA-related matters (Deviation, change control etc.), maintaining open and transparent communication channels.
Understand and address client concerns, expectations, and requirements, ensuring that our QA processes and deliverables meet or exceed their standards.
Present QA findings, reports, and recommendations to clients in a clear and concise manner, facilitating effective decision-making.
Build and maintain strong client relationships, acting as a trusted advisor and ensuring client satisfaction.


Internal Coordination:
Work closely with various departments, such as SD,DP，QC and CMC etc. to ensure seamless integration of QA processes and activities.
Coordinate and facilitate cross-departmental meetings and discussions to address quality-related concerns and drive process improvements.
Support team in handling customer complaints and inquiries related to quality, providing technical expertise and guidance as needed.
Quality Process Management:
Monitor and analyze QA metrics and KPIs to assess the effectiveness of QA processes and identify areas for improvement.
Escalate critical issues to senior management when necessary, providing detailed information and proposed solutions.


Other tasks assigned by supervisor