Project Leader Job (Shanghai, Beijing, BeiJing, ShangHai, China)
2. >7 years relevant project leadership experience in the area of pharmaceutical and or clinical development.
3. Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
4. Familiarity with the submission process to CFDA/PMDA and other regulatory standards and guidelines e.g. FDA and EMEA
5. Demonstrated success in building and leading collaborative global and cross-functional teams and relationships
6. Demonstrated facilitation and negotiation skills in driving closure on product/project related decisions/issues
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position – GLP, GMP, GCP
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
4. Drive compliance/closure of Regulatory and Quality requirements before approving project milestones
5. Identify continuous improvement activities by initiating the implementation of process and product quality improvement initiatives
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