Manager, Training Program
Listed on 2026-10-16
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Business
Regulatory Compliance Specialist
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.
Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
The Manager of Training leads the site training program for a pharmaceutical manufacturing organization, ensuring employees and contractors are qualified to perform assigned work safely, consistently, and in compliance with current Good Manufacturing Practice (cGMP), company procedures, and applicable regulatory requirements. This role partners with Quality, Operations, Technical Services, Engineering, EHS, and Human Resources to build role-based curricula, maintain inspection-ready training records, strengthen trainer capability, and improve learning effectiveness.
The position reports to the Head of Quality.
- Own and continuously improve the site training system, including governance, procedures, curricula, qualification pathways, metrics, and periodic review.
- Ensure training assignments, completions, retraining, and qualification records are accurate, timely, traceable, and inspection ready.
- Develop and maintain role-based learning plans for GxP, technical, safety, quality-system, and compliance requirements.
- Partner with process owners and subject-matter experts to convert procedures, process changes, deviations, CAPAs, and regulatory commitments into effective training.
- Oversee the learning management system and associated data integrity, access, reporting, and change controls.
- Establish standards for instructor-led training, on-the-job training, train-the-trainer programs, knowledge checks, practical demonstrations, and qualification sign-off.
- Evaluate training effectiveness using assessments, observation, performance trends, deviation data, audit observations, and stakeholder feedback.
- Provide training metrics and risk-based insights to site leadership and governance forums; escalat overdue or ineffective training as appropriate. LMS administration which oversees eQMS for tracking training (e.g., Master Control).
- Support internal audits, customer audits, and regulatory inspections by presenting the training system and retrieving supporting records.
- Lead, coach, and develop training specialists, coordinators, instructional designers, and qualified trainers, where applicable.
- Manage training vendors, materials, schedules, facilities, and budget within approved requirements.
- Promote a culture of continuous learning, quality ownership, and right-first-time execution.
- Bachelor’s degree in life sciences, engineering, education, organizational development, business, or a related field; equivalent relevant experience may be considered.
- Five or more years of experience in pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment, including at least two years in training, quality, operations, or a related leadership role.
- Working knowledge of cGMP principles, controlled documentation, data integrity,…
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