HireDiversity

Shanghai, CN

Global Quality Application Lead (Generic)-000009PL

Description

The Sr. Specialist, Learning Management System lead is the regional business owner for ensuring that that the LMS Compliance wire is maintained in a validated state of compliance. This person serves as the Company's Subject Matter Expert on the system, and will work within a cross-functional team comprised of business, Quality and Compliance and IT stakeholders from J&J Consumer globally, to monitor system functional performance, manage access controls, manage system master files, and ensure the compliant use of the system.

The Learning Management e-systems lead is responsible for developing, implementing and training on the use of Compliance wire as the Consumer Sector application for GxP Training.

Establishes the standards for Compliance Wire data segregation and denomination by region and by location to ensure accuracy and organization in the system.

Train, Qualify and provide access to the regional administrators of Compliance Wire and or training site leads.

Ensure that site training programs are deployed accurately in alignment with current standard operating procedures

Liaise, guide and work with regional training site leads to identify areas for improvement in training and eLearning programs ensure harmonization of practices across sites

Create and manage regional and global LMS User Groups and curricula. Coordinate with Local Training Leads the addition of the specific users into these groups and assignments for the global / regional curricula.

Regional Training Process Owner who provides regional audit/Inspection support with regional training management questions and training records

Manage the creation of harmonized training courses with SMEs across the region

Reviewing and approving eLearning modules for WWSPs, QSPs and global SOPs and facilitate the creation training assessments.

Organize and manage the creation and delivery of regional GxP concept training

Maintain J&J Training Server for regional training materials, including GxP training programs

Create and manage the global training curricula and assignments ensuring that they are current, accurate and deployed in alignment with current training processes. This may include, but is not limited to, consulting on and/or defining the eLearning strategy and creating/reviewing training materials for global quality applications.

Act as the Training Process expert and assist at deploying processes at local sites

Deploy a standardized program for Train-the-Trainer in his/her region. Deploy and administer the TTT program for their region.

Identify training gaps, resolve problems and drive process improvements with local training leads and local management

Act as the author for regional training/e-system administration procedures.

Manages the development and deployment of all regional and work with other regional leads in the development and deployment of global training initiatives

Deploys the standards of evaluations to local sites

Performs and manages the deployment and documentation of on-going training gap assessments for the region of responsibility

Qualifications


5 years in a regulated industry. Experience with administrating regulated LMS applications. Understands and has experience of Computer System Validation and 21 CFR part 11 requirements. Ability to assess multiple issues, and interpret the compliance and business impact, translating into system and process requirements. Capability to focus and prioritize, with the ability to multitask in a fast paced dynamic global environment. Trains others ensuring effectiveness of understanding based on the users capability and role. Strong Customer focus, maximizing users experience, reducing bureaucracy and ensuring compliance in execution.

Primary Location:Asia Pacific-China-Shanghai-Shanghai
Other Locations:Asia Pacific-China-Beijing-Beijing
Organization: Johnson & Johnson Consumer Inc. (6071)
Job Function: Quality Systems