Training Specialist (Pharmaceutical / cGMP)

Training Supervisor

Location: Keystone, Indiana

Position Summary

The Training Supervisor is responsible for overseeing and managing the site's training function, ensuring employees are properly trained, qualified, and compliant with applicable regulatory and company requirements. This position will lead a team of six training personnel and oversee the development, implementation, and maintenance of training programs supporting pharmaceutical warehouse and distribution operations.

The ideal candidate brings experience managing training programs within a regulated pharmaceutical, life sciences, or GMP environment, with a strong understanding of cGMP, GDP, documentation practices, and employee qualification requirements. This individual will provide leadership to the training team, drive consistency across training processes, and partner with Quality, Operations, and other departments to ensure workforce readiness and inspection preparedness.

Key Responsibilities

Training Team Leadership

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• Supervise, develop, and manage a team of 6 direct reports responsible for training coordination and execution.
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• Establish priorities, delegate responsibilities, and monitor team performance and productivity.
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• Coach, mentor, and develop training personnel to ensure consistent execution of training activities.
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• Establish accountability, standardize processes, and continuously improve the effectiveness of the training function.
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• Ensure adequate training coverage across operational shifts and departments.
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Training Program Management

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• Oversee the development, implementation, and maintenance of site-wide training programs, curricula, and qualification processes.
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• Ensure effective onboarding, orientation, job-specific training, cross-training, and ongoing employee development.
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• Oversee OJT (On-the-Job Training) programs, trainer qualifications, Train the Trainer and employee competency assessments.
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• Identify training gaps and partner with department leaders to develop appropriate training plans.
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• Ensure training programs remain current with SOP revisions, process changes, equipment updates, and regulatory requirements.
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Regulatory Compliance & Documentation

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• Ensure training activities comply with cGMP, GDP, applicable FDA regulations, and company quality standards.
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• Oversee training documentation, records, and employee qualification tracking to ensure accuracy, completeness, and audit readiness.
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• Ensure compliance with ALCOA+ principles, data integrity, and good documentation practices.
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• Partner with Quality to support audits, inspections, deviations, CAPAs, and training-related investigations.
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• Oversee retraining requirements resulting from SOP revisions, deviations, corrective actions, and procedural changes.
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Systems & Reporting

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• Oversee the administration and effectiveness of the site's Learning Management System (LMS).
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• Ensure accurate assignment, completion, and tracking of employee training requirements.
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• Utilize training metrics and reporting to monitor compliance, identify gaps, and drive accountability.
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• Maintain training documentation and system records in accordance with company retention and documentation requirements.
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• Work with applicable systems such as MasterControl, Veeva, SuccessFactors, and warehouse management systems.
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Cross-Functional Partnership

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• Collaborate with Quality, Operations, Warehouse, and departmental leadership to align training programs with operational needs.
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• Support training requirements for PIT (Powered Industrial Truck) operation, HazMat handling, warehouse procedures, and other job-specific qualifications.
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• Partner with operational leadership to ensure training coverage across a 24/7 warehouse environment.
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• Drive continuous improvement initiatives to strengthen training effectiveness, employee competency, and regulatory compliance.
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Qualifications

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• Bachelor's degree in Education, Organizational Development, Life Sciences, Business, or a related field preferred; equivalent experience considered.
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• 5+ years of experience in training, learning and development, or training program management within a regulated pharmaceutical, biotechnology, or life sciences environment.
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• Previous supervisory or management experience leading a training team or training function; experience managing direct reports strongly preferred.
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• Strong knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems.
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• Experience developing and overseeing structured training programs, curricula, OJT, and employee qualification processes.
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• Experience with LMS platforms and electronic training documentation systems.
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• Familiarity with MasterControl, Veeva, SuccessFactors, or similar quality and learning management systems.
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• Knowledge of ALCOA+, data integrity, and good documentation practices.
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• Experience supporting pharmaceutical warehousing, distribution, or manufacturing operations preferred.
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• Familiarity with WMS systems, PIT training, and HazMat requirements is a plus.
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• Strong leadership, communication, organizational, and problem-solving skills.
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• Ability to manage competing priorities and drive accountability in a fast-paced, regulated environment.
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