Supports and oversees the proactive and risk-based quality strategy implementation in the drug research and development activities
contributes to a culture of quality in BioNTech GDO China to positively impact the business and implement the overall strategy and vision of the Quality Organization
collaborates with key stakeholders to execute the company & department strategy, follow proactive and risk-based quality approaches, leverage Quality by Design principles, and provides QA & GCP expertise and guidance to achieve GDQA CN goals and company objectives
puts efforts to work with other GDQA CN team members, while continuously upholding the principles of transparency, speak up, and proactivity
participate in the quality projects according to quality plan under GDQA CN LT oversight for the continuous improvement initiatives
ensures that a proactive, risk-based Quality Strategy is established and implemented for trials assigned
collaborates with key internal stakeholders to ensure that clinical trial risks are detected and remediated and deviations / quality issues identified are adequately investigated
maintains a state of inspection readiness/quality dashboard that outlines key quality aspects

Bachelor’s degree in Medicine or other Life Science.
Advanced degree is preferred
Minimum 5~8 years experiences in a Good Clinical Practice (GCP) related environment
Minimum 3~5 years Drug Development Quality Assurance or GCP related quality management roles, regulatory inspection management, QMS and Training management experience preferred
People management experience preferred
Key understanding of drug research and development relevant regulations worldwide, including NMPA, FDA, EMA, and ICH
Ability to work collaboratively as part of a clinical trial team and in a cross-functional, global, matrix organization
Experience in managing escalations and CAPA support/advisement
Ability to effectively collaborate with external stakeholders
Computer literacy, including MS Office
Knowledge in the use of electronic quality management systems and ability to function independently within an environment that relies heavily on technology and computer systems
Fluent in English (written and spoken).

BioNTech 重视每一位团队成员的福祉,为多元化的员工提供全面的福利保障。我们提供具有市场竞争力的薪酬方案,具体将根据职位、工作地点及候选人资历与经验综合确定。

Associate Director, Clinical Quality Assurance Compliance

Key skills