KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

Support the Site Training program to ensure it meets all applicable regulatory requirements and is aligned with corporate policies.

• Conduct gap assessment of site training processes as assigned per applicable regulatory requirements. Resolve any compliance gaps identified.
• Support the integration of site training program into AbbVie. Support the integration GAP assessment for training procedures and processes and ensure site training procedures are aligned with corporate policies/processes and comply with site specific regulatory requirements.
• Support the development and of functional integration quality plan and/or change control per corporate requirements and timeline.
• Act as functional SME during internal audits and external audits. Identify and propose process improvement opportunities.
• Partner with Corporate to provide site support and implementation on initiatives, system upgrades, projects and procedure changes.
• Maintain the site electronic Learning Management System (ComplianceWire)
• Work with IT to and Corporate Training team to troubleshoot and resolve ComplianceWire issues, as necessary.

30%

Support training management and cross functional areas to ensure the overall effectiveness of the site training program.

• Support training management and cross functional areas to apply the best practices and identify improvement opportunities to site training program.
• Support cross functional areas to ensure all employees, including temporary employees, consultants and contractors who conduct GMP work have appropriate training plans in place; and appropriate training plans are developed for new hires and all required personnel quality records (i.e., Job descriptions and CVs) are put in place.

• Support Operations training teams in developing training materials to improve site quality culture and reduce human error NCRs.
• Managing daily activities related to training.
• Support the site annual training plan review process and ensure all cross functional management complete the annual training plan review for their employees as required.
• Coordinate site Integration leads to assign corporate procedures/policies to affected site personnel as required.
• Create custom curricula based on business requirements and employee needs. Partner with cross functional management and corporate to implement proper training to support site and corporate initiatives and projects

40%

Compile Quality metrics for QSMR, Tier board etc. Support projects and identify and bring compliance gap or quality issue and improvement opportunities to management:

• Compile and report training metrics for QSMR, site tier 2 and Tier 3. Track key performance indicators to drive learning and process improvement. Support training management to drive training initiatives, implement learning technologies and implement process improvement.
• Monitor site training metrics to ensure all functional areas within the site are effectively engaged in completing the assigned training. Escalate late training assignments to management/site tier meetings as needed.
• Create custom weekly and monthly training reports as needed for managers to ensure training compliance.
• Participate/lead training related project teams to ensure timely completion of project with quality. Report project status to upper management as needed.
• Coach junior team members in the creation, monitoring of training metrics

15%

Support Change Control process to identify affected training curriculums and ensure proper trainings are assigned and the trainings are effective

• Review and approve training strategies for upcoming change controls to ensure proper means are used for training
• Review DCCs to ensure required training are assigned
• Measure training effectiveness as needed post implementation to ensure continued and measurable success of the implemented projects/process changes
• Develop criteria to evaluate the effectiveness of training activities, including but not limited to quizzes, surveys and process confirmation observations.

15%