Under the supervision of Quality Compliance management, the supervisor/manager for quality training will support all aspects of the site training processes which include but not limited to the activities listed below. Complies with FDA, ISO, AATB, and all other applicable international, national and state regulatory requirements, best industry practices, AbbVie corporate and internal processes. Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified.
- Ensure Site Training program meets all applicable regulatory requirements and is aligned with corporate policies.
- Support cross functional management in ensuring all employees, including temporary employees, consultants and contractors who conduct GMP work have appropriate training plans in place.
- Manage the quality training team. Supervise/mentor/coach direct reports in accomplishing their job function responsibilities and support their career development.
- Monitor the status of site trainings to ensure all required trainings are completed timely.
Supervisory responsibility: (if applicable)
Manages one group, which includes directly supervising 3-5 employees with the authority to hire, promote and manage the performance of these employees.
KEY DUTIES AND RESPONSIBILITIES: Describe scope:
% of Time or
Ensure Site Training program meets all applicable regulatory requirements and is aligned with corporate policies.
- Evaluate site training program per applicable regulatory requirements as needed. Conduct assigned gap assessment and resolve any compliance gaps identified.
- Lead the integration of site training program into AbbVie. Perform integration GAP assessment for training procedures and processes and ensure site training program is aligned with corporate policies/processes and comply with site specific regulatory requirements.
- Ensure functional integration quality plan and/or change control is developed and approved per corporate requirements and timeline.
- Act as functional SME during internal audits and external audits Develop and implement process improvements, regarding the support of training and the LMS.
- Work with Operations training teams to develop training materials to improve site quality culture and reduce human error NCRs.
- Benchmark best industry practice to improve site training program.
Support cross functional management in ensuring all employees, including temporary employees, consultants and contractors who conduct GMP work have appropriate personnel quality records in place.
- Work with cross functional management to ensure all employees have an appropriate training plan in place. Lead the site annual training plan review process and ensure all cross functional management complete the annual training plan review for their employees as required.
- Ensure site personnel quality records (i.e., Job descriptions and CVs) are in place and reviewed annually and updated timely as needed.
- Work with functional area management to ensure an appropriate training plan is developed for new hires and all required personnel quality records are put in place.
- Coordinate with corporate to ensure corporate procedures/policies are assigned to affected site personnel as required.
Manage the quality training team. Supervise/mentor/coach direct reports in accomplishing their job function responsibilities and support their career development.
- Oversee, direct, coordinate, and prioritize the daily activities of the Quality training department to ensure all business needs are satisfied.
- Conduct one on one and Time to Talk meetings with all direct reports and ensure all associates have career development plan in place.
- Provide support, direction and coaching to subordinate employees to resolve any issues encountered during daily work. Support their career development plans.
- Ensure the team are cross trained on all business processes and activities within the functional area.
Monitor the status of site trainings to ensure all required trainings are completed timely.
- Develop and maintain an annual training schedule/calendar. Ensure all required annual trainings are assigned properly in accordance with procedural and applicable regulations/standards requirements
- Review and approve training strategies for upcoming change controls to ensure proper means are used for training.
- Compile Quality metrics for QSMR, Tier board etc. and identify and bring issues to management when a compliance gap or quality issue is identified
- Monitor site training metrics to ensure all functional areas within the site are effectively engaged in and completing the assigned training. Escalate late training assignments to site tier meetings as needed.
Education and Experience
- BA or BS Degree, or equivalent experience preferred
- 3+ years of Training or leadership experience in Medical Device, Pharmaceutical, Human Tissue or Biotech industry.
- Familiar with Microsoft Office Applications including Word, Excel, PowerPoint and Outlook.
- Ability to work on cross functional teams and apply influencing skills in a matrix environment along with the ability to partner with and influence key internal and external stakeholders.
- Experience with training content development and associated programs/technology.
- Demonstrated experience with implementing and managing electronic learning management systems (LMS).
- Ability to aseptically gown and work in a controlled processing environment working with human and animal tissues.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced