GMP Training Leader - Pharma Ops & Compliance

Premier Staffing Solution, LLC; New Whiteland (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Premier Staffing Solution, LLC is seeking a Training Supervisor to lead a six-person team responsible for developing, implementing, and maintaining training programs for pharmaceutical warehouse and distribution operations.

The ideal candidate has experience in regulated pharma/Life Sciences environments, with strong knowledge of cGMP, GDP, FDA regulations, and data integrity. The role partners with Quality and Operations to ensure workforce readiness and inspection preparedness.

Qualifications

• Bachelor's degree in Education, Organizational Development, Life Sciences, Business, or a related field preferred; equivalent experience considered.
• 5+ years of experience in training, learning and development, or training program management within a regulated pharmaceutical, biotechnology, or life sciences environment.
• Experience supervising or managing a training team; experience with direct reports preferred.
• Strong knowledge of cGMP, GDP, FDA regulations, and pharmaceutical quality systems.
• Experience developing and overseeing structured training programs, curricula, OJT, and employee qualification processes.
• Experience with LMS platforms and electronic training documentation systems.
• Familiarity with MasterControl, Veeva, SuccessFactors, or similar systems.
• Knowledge of ALCOA+, data integrity, and good documentation practices.

Responsibilities

• Supervise, develop, and manage a team of 6 direct reports responsible for training coordination and execution.
• Establish priorities, delegate responsibilities, and monitor team performance and productivity.
• Coach, mentor, and develop training personnel to ensure consistent execution of training activities.
• Establish accountability, standardize processes, and continuously improve the effectiveness of the training function.
• Ensure adequate training coverage across operational shifts and departments.
• Oversee the development, implementation, and maintenance of site-wide training programs, curricula, and qualification processes.
• Ensure onboarding, orientation, job-specific training, cross-training, and ongoing employee development.
• Oversee OJT programs, trainer qualifications, Train the Trainer and employee competency assessments.
• Identify training gaps and partner with department leaders to develop appropriate training plans.
• Ensure programs remain current with SOP revisions, process changes, equipment updates, and regulatory requirements.
• Ensure training activities comply with cGMP, GDP, applicable FDA regulations, and company quality standards.
• Oversee training documentation, records, and employee qualification tracking to ensure accuracy, completeness, and audit readiness.
• Ensure ALCOA+ principles, data integrity, and good documentation practices are followed.
• Partner with Quality to support audits, inspections, deviations, CAPAs, and training-related investigations.
• Oversee retraining requirements from SOP revisions, deviations, corrective actions, and procedural changes.
• Oversee LMS administration and effectiveness; track assignment and completion of training requirements.
• Utilize training metrics to monitor compliance, identify gaps, and drive accountability.
• Maintain training documentation and system records per retention requirements.
• Work with systems like MasterControl, Veeva, SuccessFactors, and warehouse management systems.
• Collaborate with Quality, Operations, Warehouse, and leadership to align training with operational needs.
• Support PIT training, HazMat handling, warehouse procedures, and other job-specific qualifications.
• Partner with leadership to ensure training coverage in a 24/7 warehouse environment.
• Drive continuous improvement to strengthen training effectiveness, competency, and compliance.

Skills

Leadership

cGMP knowledge

Regulatory compliance

OJT management

Training program development

Documentation practices

Education

Bachelor's degree in Education/Org Development/Life Sciences/Business or related

Tools

MasterControl

Veeva

SuccessFactors

Job description

Premier Staffing Solution, LLC is seeking a Training Supervisor to lead a six-person team responsible for developing, implementing, and maintaining training programs for pharmaceutical warehouse and distribution operations.

The ideal candidate has experience in regulated pharma/Life Sciences environments, with strong knowledge of cGMP, GDP, FDA regulations, and data integrity. The role partners with Quality and Operations to ensure workforce readiness and inspection preparedness.