Manages the Technical Training process and resources supporting the Tijuana site to ensure the successful alignment and execution of Technical Training strategies, initiatives, and processes. Responsible for all aspects of Technical Training including the design, coordination, and deployment of role-based training. Periodically conduct live training for managers, process owners, and SME trainers with the various regulations that apply to Tijuana.

What you will do:

•    Provide leadership and direction to training team members within the site.
•    Partner with the business, as the training process and systems expert, to advise on training initiatives/solutions.
•    Lead the implementation or improvement of training systems, procedures, and processes.
•    Partner with managers, process owners and subject matter experts to assess training needs for their functional area(s) of responsibility; assist in translating needs into training requirements/solutions.
•    Implement processes to ensure accurate training is assigned and evaluated periodically.
•    Complete training workflow tasks within onePLM to ensure accurate training is being planned and assigned in the LMS when new or revised documents are released.
•    Support, or own, NC/CAPAs related to training outcomes/processes, drive resolution.
•    Oversee the design, development, and customization of technical training content.
•    Ensure the proper documentation of training programs.
•    Monitor and respond to changes in SLMS data that have the potential to impact the reliability and/or automation of training assignments.
•    Empower managers and process owners on their responsibilities within the training process, provide tools and resources to enable and sustain their success.
•    Develop systems that ensure the effectiveness of training delivery and effectiveness.
•    Generate and distribute training metrics/Key Performance Indicators (KPIs), monitor progress and take timely action to address adverse trends and deviations.
•    Partner with functional groups (e.g., Manufacturing, Quality, Sterility, HR, etc.) to incorporate functional-based training into role-based curriculums, as appropriate.
•    Participate in communities of practice (COPs) that seek to improve strategies, programs, and processes across the Technical Training function; lead tactic teams if necessary. 
•    Ensure training process compliance with regulatory standards and quality requirements.
•    Ensure compliance to the Mexican Labor regulation for Training Art. 153, generates and maintain records to demonstrate compliance with local and federal authorities.
•    Collect and present on training performance metrics to leadership during periodic meetings and forums (e.g., Quality Systems Management Review).
•    Represent Technical Training processes during regulatory body audits/inspections and support requests for training records and/or evidence for qualification.
•    Partner with the SLMS Shared Services Team to support platform upgrades, enhancements, and ensure help ticket Service Level Agreements (SLAs) are being met; identify process improvements where possible.
•    Communicate system issues affecting the business’ ability to conduct and/or document training to drive awareness and timely resolution.   
•    Deliver live training (e.g., Train-the-Trainer, Manager/Process Owner Orientations), as needed.
•    Provide support to other functions, related to training needs and compliance.
•    Conduct Gemba walks to monitor performance and identify improvements, as needed.
•    Perform additional duties and projects, as assigned.

What you need:

•    Fully Bilingual (written & spoken).
•    Strong knowledge of Mexican FLL (Art. 153) and Mexican Official Standard (IMSS).
•    Strong knowledge of GMPs, ISO13485, and 21CFR820 requirements.
•    Good analytical skills.n.
•    Excellent computer skills, including proficiency in MS Office Suite and strong excel skills

•    5 years minimum of experience working in a highly regulated quality and/or compliance environment.
•    Prior experience leading project teams and/or supervising others.
•    Demonstrated experience working with Learning Management Systems (LMS), document management, and change control processes.
•    Prior experience working with, or implementing, a Manufacturing Execution System (MES) with a training system integration. 
•    Experience supporting training processes for manufacturing operations.
•    Working knowledge in Good Manufacturing Practices (GMPs) and Quality System Regulations. 
•    Knowledge of training needs analysis, instructional/program design, development and evaluation, adult learning concepts and learning methodologies a plus.
•    Bachelor’s degree with concentration or emphasis in Training & Development, Education, Quality, Business, Psychology, Engineering, or related field.