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Job Function:
Quality
Job Sub Function:
Clinical Quality
Job Category:
Professional
All Job Posting Locations:
Shanghai, China
Job Description:
Main responsibilities will include, but are not limited to:
Auditing
Independently leads the planning, conduct and reporting of R&D Quality QA routine and non-routine audits of activities, data, internal facilities and processes in GxP/non-regulated to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. May support other auditors in planning, conduct and reporting of audits.
Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
Inspection Support
Training & Development
People Management
Project Management
Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.
Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress.
Subject Matter Expert / Point of Contact
Provides expertise and knowledge to less experienced auditors, Business Partners and the core business sector on quality and compliance processes/procedures. Interprets and applies regulations/ policies to issues of moderate complexity, when required.
Required Skills:
Preferred Skills:
Audit Management, Business Alignment, Business Savvy, Clinical Research and Regulations, Clinical Trials Operations, Coaching, Collaborating, Communication, Compliance Management, Data Analysis, Escalation Management, Fact-Based Decision Making, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Tactical Thinking, Vendor Selection
