Sr. Quality Training Manager

Becton Dickinson Medical Devices•El Paso, TX

About The Position

The Sr. Quality Training Manager leads the training specialist team and partners with Operations, Engineering, EHS, and HR to design, deliver, and verify effective training. The role owns the site training system and ensures accurate, complete, inspection-ready records; consistent training across shifts; and sustainable correction of training-related root causes. It builds hands-on training for floor associates and champions a quality culture centered on product quality and patient safety. As a core member of the Pharma Center of Excellence (COE), the manager helps develop a shared training program for the El Paso and Sandy sites and leads training and qualification activities supporting site transformation. The role oversees training compliance, effectiveness, content and delivery, trainer qualification, onboarding, cross-training, quality-culture initiatives, metrics, audit readiness, and the development of Training Specialists. The position requires a bachelor's degree in a scientific, engineering, education, or related field; at least seven years of experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment, including at least three years in training, quality, or curriculum development; and at least four years supervising or leading people. The role also requires working knowledge of applicable cGMP, data-integrity, documentation, medical-device quality, and ISO requirements, hands-on LMS administration, and proficiency with Microsoft Office.

Requirements

Bachelor’s degree in a scientific, engineering, education, or related field.
At least 7 years of experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment.
At least 3 years of experience in training, quality, or curriculum development.
At least 4 years of experience supervising or leading people.
Demonstrated working knowledge of pharmaceutical cGMP (21 CFR Parts 210/211), 21 CFR Part 11, and Good Documentation Practices.
Working knowledge of 21 CFR Part 820 (QMSR) and ISO 13485:2016.
Hands-on experience administering a Learning Management System.
Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.

Nice To Haves

Experience supporting FDA inspections and/or notified body audits.
Experience with root cause analysis and CAPA, including human-error investigation methods.
Instructional design certification or training, such as ADDIE, and experience measuring training effectiveness.
Lean/Continuous Improvement training experience; Green Belt preferred.
Experience building hands-on, floor-based training programs, such as TWI Job Instruction, training cells, and skills matrices.
Experience leading quality-culture or employee-engagement initiatives.
Combination-product experience under 21 CFR Part 4 and knowledge of ICH Q7/Q9/Q10 and EU GMP/PIC/S.
Experience with sterile or aseptic manufacturing training and qualification, such as gowning and aseptic process simulation.
Experience supporting multi-site programs, harmonization, or site transformation/change management.
Bilingual English/Spanish.

Responsibilities

Lead the Training Specialist team, including setting goals, coaching and developing team members, holding regular one-on-ones, and completing annual performance reviews.
Own site training procedures and the training and qualification process, ensuring compliance with applicable pharmaceutical, medical-device, combination-product, ISO, corporate, and regulatory requirements.
Establish and maintain role-based training matrices and curricula, updating them when procedures, processes, equipment, or roles change.
Ensure associates have current documented training and required on-the-job qualification before performing GMP tasks; oversee timely assignment and completion of training and escalate overdue training.
Administer the Learning Management System, including curricula mapping, user access, record accuracy, and reconciliation against the training matrix; ensure records meet GDP and ALCOA+ principles and are audit-ready.
Define and apply risk-based methods for verifying training effectiveness, such as knowledge checks, observed demonstrations, qualification sign-offs, and performance indicators.
Partner with Quality on nonconformance, CAPA, complaint, and audit investigations to assess training as a potential cause; develop training-related CAPA actions and provide evidence of effectiveness.
Trend human-error and training-related events, identify systemic gaps, and improve training content, delivery, and process design.
Deliver onboarding and periodic training in cGMP, GDP, data integrity, quality awareness, and applicable pharmaceutical-specific topics.
Design, develop, and maintain training content, including on-the-job training materials, task documents, videos, presentations, and job aids aligned with controlled procedures.
Lead the trainer and qualifier program, including selection, certification, and periodic requalification of on-the-job trainers.
Improve new-associate onboarding and ensure associates are qualified before independent work; make training consistent across shifts and production areas.
Develop cross-training and certification programs with Operations, Engineering, and EHS, and support strategic curricula such as Lean/Continuous Improvement and leadership development as needed.
Build and own a structured, hands-on floor-associate training program using standardized on-the-job methods, proficiency levels, observed sign-offs, workstation training aids, and training cells or practice areas.
Maintain area skills/flexibility boards, conduct floor observations, and ensure periodic requalification and refresher training for critical operations and tasks with recurring errors.
Lead quality-culture initiatives with Quality leadership, embed quality behaviors in training, promote a Right First Time mindset, and equip supervisors and team leads to coach quality behaviors.
Measure quality culture using surveys, observations, and leading indicators, and report trends to leadership.
Help design and implement a standard Pharma COE training program for the El Paso and Sandy sites; harmonize procedures, curricula, matrices, LMS setup, and qualification methods where appropriate.
Lead the training and qualification workstream for site transformation projects, assess training maturity and gaps, manage a prioritized improvement roadmap, and develop training and change-readiness plans.
Share best practices between sites and develop a network of site trainers and subject matter experts; report COE training progress, risks, and metrics to leadership.
Establish and report training KPIs at site Quality Management Review and operations meetings.
Serve as the site training subject matter expert during audits and inspections, present training systems and records, conduct periodic self-inspections, and drive closure of identified gaps.
Provide training compliance status updates and escalate risks and issues to Quality leadership while keeping Operations leadership informed.
Comply with applicable BD quality and safety policies and procedures, including RCRA hazardous waste regulations; perform other job-related duties as required.