Nature and Scope

Provides direct supervision and leadership to assigned training personnel responsible for operational training, on-the-job training, workforce qualification, and training-related quality support across assigned functional areas. Establishes priorities, assigns and monitors work, evaluates performance, coaches and develops staff, and ensures consistent, effective execution of training activities. Holds training personnel accountable for maintaining accurate documentation, qualification controls, regulatory compliance, and timely delivery of business-critical training. Partners cross-functionally to ensure employees are trained, qualified, and released to perform work in accordance with business needs, internal procedures, and applicable regulatory expectations.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• 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; escalate 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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor’s Degree or equivalent combination of education and relevant experience, required.
• Minimum of four years of relevant experience in training within operations, manufacturing, quality, laboratory, pharmaceutical, biotechnology, medical device, or another regulated environment required.
• Experience with operational training, OJT, workforce qualification, practical skills assessment, training documentation, and employee-readiness tracking preferred.
• 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 required.
• 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.

Expected Salary Range:

$90,000-$105,000

The salary range, displayed is the  minimum and maximum annual salary of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.  Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide

range of other benefits.