Sr. Quality Training Manager



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Job Description

The role leads the training specialist team and partners with Operations, Engineering, EHS, and HR to design, deliver, and verify the effectiveness of training. The Training Manager ensures training records are complete, accurate, and inspection-ready, that training is consistent across all shifts, and that training-related root causes identified through nonconformances, CAPAs, complaints, and audits are corrected effectively and sustainably. The role builds an effective, hands-on training program for floor associates and champions a strong quality culture in which every associate understands their impact on product quality and patient safety. As a key member of the Pharma Center of Excellence (COE), the role helps build out the Pharma COE training program and supports the transformation of both sites.

Training System Ownership and Compliance

Own the site training procedure(s) and the training and qualification process, ensuring compliance with 21 CFR Parts 210/211 (pharmaceutical cGMP), 21 CFR Part 820 (QMSR), 21 CFR Part 4 (combination products), ISO 13485:2016, applicable ICH guidelines (Q7, Q9, Q10), EU GMP / PIC/S where applicable, BD corporate requirements, and other applicable regulatory agency expectations.

Establish and maintain a role-based training matrix/curricula for every department and job role, in collaboration with department leaders and Quality, and ensure it is updated when procedures, processes, equipment, or roles change.

Ensure no associate performs a GMP task without documented, current training and, where required, on-the-job qualification or certification.

Ensure timely assignment and completion of training for new and revised controlled documents (SOPs, work instructions, forms) prior to their effective date or use, and escalate overdue training to management.

Administer and maintain data integrity of the Learning Management System (LMS), including curricula mapping, user access, record accuracy, and periodic reconciliation against the training matrix.

Ensure training records meet Good Documentation Practices (GDP) and ALCOA+ principles and are retrievable for audits and inspections.

Training Effectiveness and Quality Linkage

Define and apply risk-based methods to verify training effectiveness (e.g., knowledge checks, observed demonstrations, qualification sign-offs, and performance indicators such as error and deviation trends).

Partner with Quality on nonconformance, CAPA, complaint, and audit investigations to assess whether training is a contributing or root cause; avoid using retraining as a default corrective action unless supported by root cause analysis.

Develop and execute training-related CAPA actions and provide objective evidence of effectiveness within committed timelines.

Trend human-error and training-related events, identify systemic gaps, and drive improvements in training content, delivery, and process design.

Ensure cGMP, GDP, data integrity (21 CFR Part 11 and FDA data integrity guidance), and quality-awareness training is delivered at onboarding and refreshed at defined intervals, consistent with the 21 CFR 211.25 requirement for continuing GMP training.

Include pharmaceutical-specific training where applicable, such as aseptic technique and gowning qualification, contamination control, cleaning and line clearance, batch record execution, and handling of APIs and materials.

Program Development and Delivery

Design, develop, and maintain training content (structured on-the-job training, task documents, videos, presentations, job aids) that is accurate, current, and aligned to controlled procedures.

Lead the trainer/qualifier program, including selection, certification, and periodic requalification of on-the-job trainers.

Lead and continuously improve new-associate onboarding to ensure associates are qualified before independent work.

Ensure training content and delivery are consistent across all shifts and production areas.

Develop cross-training and certification programs with Operations, Engineering, and EHS to increase workforce flexibility without compromising compliance.

Support site goals with strategic curricula, including Lean / Continuous Improvement and leadership development as needed.

Hands-On Floor Associate Training Program

Build and own a structured, hands-on training program for floor associates that relies on demonstration and practice at the point of use, not just reading SOPs or classroom sessions.

Implement a standardized on-the-job training method (e.g., Tell–Show–Do–Review / Job Instruction model) used consistently by all trainers on all shifts.

Establish defined proficiency levels for each operation (e.g., in training, qualified, trainer) with observed demonstration sign-off by a qualified trainer before an associate works independently.

Develop visual, operator-friendly training aids at the workstation (one-point lessons, visual work instructions, defect libraries, good/bad part boards) that align with controlled documents.

Partner with Engineering and Operations to set up training cells, simulation stations, or offline practice areas so associates can build skills without affecting production or product quality.

Maintain a skills/flexibility board for each area showing who is qualified on which operations, to support staffing, cross-training, and coverage across shifts.

Conduct regular floor observations (Gemba walks) to confirm associates follow procedures as trained; use findings to improve training content and coaching.

Ensure periodic requalification and refresher training for critical-to-quality operations, inspection tasks, and operations with recurring errors.

Quality Culture

Lead site quality culture initiatives with Quality leadership, so associates understand how their work affects product quality and patient safety (including Line-of-Sight to Patient / Voice of the Patient sessions).

Embed quality behaviors in all training: following procedures as written, Good Documentation Practices in real time, stopping and escalating when something is not right, and speaking up without fear.

Promote a “Right First Time” mindset and teach associates to recognize, contain, and report defects, deviations, and near misses.

Develop quality awareness and data integrity modules for onboarding and annual refreshers, using real site examples (e.g., recent nonconformances, complaints, and audit observations).

Equip supervisors and team leads to coach quality behaviors on the floor and reinforce them through daily tier meetings and recognition programs.

Measure quality culture through associate surveys, observation results, and leading indicators (e.g., near-miss reporting, GDP errors, human-error deviations) and report trends to leadership.

Pharma COE Training Program and Site Transformation

Serve as a core member of the Pharma Center of Excellence (COE) team, helping design and build out a standard COE training program for the El Paso and Sandy sites.

Harmonize training procedures, curricula, training matrices, LMS setup, and on-the-job qualification methods across both sites, with site-specific content only where processes truly differ.

Build a single COE training framework that covers both pharmaceutical cGMP (21 CFR 210/211, ICH Q7/Q9/Q10, EU GMP where applicable) and medical device / combination product requirements (21 CFR 820, 21 CFR Part 4, ISO 13485).

Lead the training and qualificat