Training Supervisor

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

Benefits offered by this job

Healthcare

Life Insurance

Profit Sharing

Paid Time Off

401k Matching

Job summary

American Regent, Inc. is seeking a senior training leader to supervise the training staff and drive readiness across operations. You will establish priorities, coach staff, manage documentation, and ensure timely delivery of regulated training programs.

Responsibilities include overseeing OJT qualification, cross-functional collaboration, and maintaining training materials while supporting CAPAs and quality events. A strong GMP background and effective communication are essential.

Qualifications

• Bachelor’s Degree or equivalent with relevant experience.
• Minimum four years in training within regulated environments.
• Experience with OJT, workforce qualification, and documentation expectations.
• Knowledge of GMP, quality systems and 21 CFR requirements.
• 1–3 years of leadership including coaching/mentoring.

Responsibilities

• Directly supervise and lead training personnel, set performance expectations, and monitor workloads.
• Oversee OJT programs, qualification processes, and trainer/evaluator activities.
• Track training completion, qualification status, and related risks.
• Develop and revise training materials and assessments to meet procedures.
• Support deviations and CAPAs by reviewing training history and gaps.

Skills

Leadership

Training delivery

Coaching & mentoring

Regulatory compliance

Documentation control

Education

Bachelor's Degree

4+ years training ops

Leadership experience

Job description

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; 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.

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

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.

Salary and Total Rewards Package

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.

Diversity and Inclusion

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.

Know Your Rights

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlA

Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

Company Overview

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.