Under the direction of the Regional Quality Systems Director, the Regional Quality Systems Training Coordinator for J&J Consumer will be responsible for supporting the end-to-end (E2E) oversight and effectiveness of the Consumer Quality Training System for the EMEA region.
The Regional Quality Systems Training Coordinator is responsible for working with all functions at all sites within the region to drive standardization as well as ensure representation for all functions within the Consumer Global Quality Management Training System.
- Ensure that Training processes are in alignment with Consumer Sector procedure and Enterprise standards.
- Working with all functions to ensure on-time training metric is consistently delivered across the EAME region. Duties include monthly collection, review & reporting of training metrics and effectiveness, together with responsibility to ensure routine (weekly) pre-emptive and follow-up of on-time time training with trainees across the region
- To be the regional lead and SME for Training process as per global procedure and playbook and provide associated process, training and support across the region.
- To be the regional lead and SME for the Consumer eLearning Management System, and first regional point of contact with local eLMS admins for all application administrative aspects including process, configuration, functionality, issue resolution and, if necessary escalation and resolution with global eLMS application owners
- Propose, identify, communicate and implement as needed new or revised Training processes or applications for the region to ensure continued compliance with global regulatory standards and new/changing regulations pertaining to training requirements
- Responsible for Training standardization within Consumer across regions. Collaborate w/ Enterprise on standardization initiatives and deployment of new IT solution/process within Consumer
- To be the point of regional point of contact for:
- Global Quality Systems Working Council Training Focus Team
- JJQS P&P Training Team
- EMEA Source, Make and BQ Quality Regional QS teams
- Local site eLMS/ Training admins
- Consumer EAME Training CoE (Leading role)
- Support Regulatory Inspection preparedness and management and also provide remote Quality Systems support for Regulatory inspections at sites within the region
- The Regional QS Training Coordinator will also have responsibility for supporting the following processes:
- Consultant to the Content Owners on the development of training materials.
- Partner with Functional Area Managers to identify personnel training needs
- Maintain training documentation utilizing an LMS or other controlled method
- Determine whether internal or external training qualifies as GxP Concept Training
- Assist in identifying training audience for new/revised procedures within their area of responsibility.
- Required: Undergraduate degree in technical or life science or equivalent years of experience.
- Coordinator: At least three (3) years in the field of Quality Systems and Compliance within regulated medical industry.
- Regulatory inspection experience highly desirable
- Track record of successful cross functional partnership and experience of highly matrixed organizations
- Track record of resolving compliance issues
Knowledge, Skills and Abilities:
- Working knowledge of applicable international healthcare, medical device and cosmetic regulatory requirements for Quality Issues Management within regulated healthcare industries.
- Excellent written, verbal and presentation communication skills
- Excellent Training skills
- Must be able to develop and maintain relationships/partnerships and to work collaboratively both internally and externally
- Experience of eLMS systems
- Change management and Project management experience
- Excellent MS Office and Office 365 skills
- Highly organized and willing to undertake significant responsibility whilst also undertaking a significant amount of routine administrative duties
- Self-starter, objective driven and confident to work remotely without daily supervision/oversight.
- Location of Role: Regional
- Language Requirements: English
- Travel Requirements: 5% with higher peaks depending on needs