職位描述
職位描述：
Major Responsibilities：
1.Project Management: deployment of eLIMS & Empower in collaboration with the global team;
2.Assure R&R are clear for all team members;
3.Drive and support site readiness for eLIMS & Empower implementation;
4.Follow-up and tracking via the Site Implementation Leads of tasks in the following areas:
1)SOP’s & Training
2)Change Control
3)Implementation Risk Assessment
4)Business Implementation Plan / Report
5)Dry-run of the system
6)Go-live of the system
7)IT deliverables: Hardware Requirements / Legacy system retirement plan
5.Coach and guide all applicable sub team leads to reach their goals;
6.Align and harmonize any customer requirements;
7.Support problem solving and issue resolution during the different phases of the project and after go live
8.Post go live support.
Qualifications：
1.A minimum of a Bachelors degree required;
2.Excellent written and verbal communication skills (English) are required;
3.A minimum of 5 years of experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) is required;
4.Extensive knowledge of lab environment is required;
5.Knowledge of LIMS is preferred;
6.Demonstrated knowledge of applicable regulations (e.g., FDA, ICH Q8, 9, 10) is required;
7.Demonstrated experience directly and/or indirectly leading a group of professionals to achieve business objectives is preferred;
8.Flexible and capable of working with people over distance is required;
9.Strong project management skills are required;
10.Strong Problem-solving and Change management skills are required;
11.Lean-approach oriented is preferred;
12.Excellent negotiation, partnering and influencing skills are required;
13.Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, supply chain processes,…)is preferred;
14.Ability to build and nurture strong, positive relationships with business leadership, customers and partners in Lab Systems, IT, Manufacturing and other Quality functional groups is required;
15.Travel up to 20% is required.
