Primary Responsibilities:
- Provide QA expertise and support for China cross-functional projects especially those collaboration/integration projects including but not limited to develop QA plan and/or conduct clinical audits; or oversees the execution of above activities by QA individual team members by providing guidance, assigning tasks and ensuring that QA team members are productive and engaged.
- Oversees team of individuals by providing guidance for daily tasks and operations, as applicable
- Facilitates communication and alignment with key stakeholders upstream and downstream
- Addresses challenges and opportunities to enhance performance and supports the growth and development of individual leaders
- Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risk-based audits
- GCP routine and directed audits of investigator sites, country offices, suppliers, , third party collaborations and due diligence activities.
- Represents QA as single point of contact for Clinical Trial Teams (CTT) and provides QA guidance for studies in a certain program/indication or in certain countries.
- In alignment with risk assessments, support the QALs in the identification of audit substrate for scheduling, as appropriate.
- Participate in Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as deemed appropriate by the QAL.
- Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.
- Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies.
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Assesses compliance of clinical investigator sites, suppliers, study activities, clinical study reports and submission documents (as appropriate), and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as company policies, procedures and industry standards. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally.
- Promotes standardization of auditing approach within QA.
- Routinely suggests new audit techniques/aids in areas of technical expertise
- Actively participate in special assignments on various project teams as determined by QA management.
- Provides training and mentorship to less experienced members of QA staff.
- Ensures the work climate/culture within QA, exemplifies the R&D Leadership behaviors
Education and Experience
- BS/BA degree or above in Clinical Medicine, life science or pharmacy.
- Clinical development knowledge system, capabilities in multiple therapeutic areas or GxP quality management, and In-depth clinical regulations insight and expertise.
- 6+year previous experience in Clinical quality assurance or quality management or GCP Inspection management, 10+years industry experience.
- Clinical audit experience is preferred, due Diligence or cross-functional cooperation projects is a plus.
- Diverse working experience, including different stages of clinical research, and/or working in MNC/ Biotech, is a plus.

Personality traits and Competence
- Self-driven, dedicated, persistent, strategic, flexible and fast learning
- Sensitive to in/external environment change.
- Internal and external cooperation.
- Execution Excellence: Commitment to deliverables, taking prompt action to accomplish work goals, per compliance standards; taking action to achieve results beyond what is required; being proactive
- The ability to identify, proactively manage and mitigate risk to achieve quality outcomes
- Excellence in Communication and Collaboration Skills, Fluent in English
- Capable of engaging internal and external stakeholders, adapting to the mindset of experimental and innovative collaboration.
- Influence: Influence stakeholders and help competitive decision-making. Have the basis, reason or convincing ability to make decisions and make the right decisions in the face of differences.