Operations Training Lead – GMP & Qualification

American Regent, Inc.; Town of Brookhaven (NY); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Healthcare

Life Insurance

Profit Sharing

Paid Time Off

401k Match

Job summary

American Regent, Inc. is seeking a Training Supervisor to lead the training team across operations, manufacturing, quality, and regulatory support. You will set priorities, coach staff, monitor performance, and ensure documentation and qualification controls are compliant.

You will partner with department leaders to align training with procedures and regulatory expectations. The role includes implementing OJT and qualification processes, tracking readiness, developing materials, and supporting

Qualifications

• Bachelor’s Degree or equivalent combination of education and relevant experience.
• Minimum of four years of relevant experience in training within operations, manufacturing, quality, laboratory, pharmaceutical, biotechnology, medical device, or another regulated environment.
• Experience with operational training, OJT, workforce qualification, practical skills assessment, training documentation, and employee-readiness tracking.
• Working knowledge of GMP, quality systems, training-documentation expectations, and applicable regulatory and safety requirements, including 21 CFR.
• 1 to 3 years of leadership experience including and/or has demonstrated success the ability to lead, coach or mentor a team or group.
• Demonstrated experience directly supervising, coaching, mentoring, and developing training personnel including assigning and monitoring work, setting expectations and delivering performance expectations.
• Strong organizational, communication, documentation, follow-up, coaching, problem-solving, and cross-functional collaboration skills.
• Ability to maintain access to aseptic processing areas, including gowning and aseptic qualifications.

Responsibilities

• Directly supervise and lead assigned training personnel, including establishing performance expectations, assigning and prioritizing workloads, monitoring work quality and completion, providing ongoing coaching and timely performance feedback, addressing performance or conduct concerns, supporting development and succession planning, and fostering accountability, collaboration, and continuous improvement within the training team.
• Oversee operational training programs that support employee readiness across assigned functional areas, partnering with department leaders and SMEs to align training requirements with current procedures, job tasks, equipment, process changes, operational priorities, and regulatory expectations.
• Implement and maintain OJT and job/task qualification processes, including qualification requirements, OJT checklists, practical evaluations, skill signoffs, qualification evidence, training-documentation controls, release-to-work controls, and trainer/evaluator qualification activities.
• Oversee the day-to-day execution of operational training delivery, cross-training, practical qualification, trainer support, and learner progression in partnership with learners, trainers, evaluators, supervisors, managers, and subject matter experts.
• Track workforce readiness, including training completion, qualification status, overdue OJT, task restrictions, cross-training progress, and related risks; elevate concerns that may affect operations, quality, safety, inspection readiness, or an employee’s release to perform work.
• Create, revise, and maintain training materials, job aids, assessments, curricula, and related learning resources and assignments to support approved procedures and operational requirements.
• Support deviations, CAPAs, quality events, audit observations, inspection requests, and performance concerns by reviewing training history and qualification evidence, identifying training or qualification gaps, recommending corrective responses based on root cause and risk, and tracking assigned training commitments to closure.
• Monitor training effectiveness, KPIs, and qualification trends to identify systemic risks, performance gaps, and improvement opportunities.
• Perform any other tasks/duties as assigned by management.

Skills

Leadership

Team supervision

Training coordination

Regulatory compliance

Cross-functional collaboration

Coaching

Education

Bachelor’s Degree

Job description

American Regent, Inc. is seeking a Training Supervisor to lead the training team across operations, manufacturing, quality, and regulatory support. You will set priorities, coach staff, monitor performance, and ensure documentation and qualification controls are compliant.

You will partner with department leaders to align training with procedures and regulatory expectations. The role includes implementing OJT and qualification processes, tracking readiness, developing materials, and supporting