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August Bioservices, a high-growth Contract Development Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee, is seeking a Manager of Training Program to own and continuously improve the site's training system. The company provides drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies and is undergoing a significant two-phase expansion.
In this role, you will be responsible for establishing and maintaining comprehensive training governance, procedures, curricula, and qualification pathways across the organization. You will ensure all training assignments, completions, retraining, and qualification records are accurate, timely, traceable, and inspection-ready. Key responsibilities include developing role-based learning plans for GxP, technical, safety, quality-system, and compliance requirements; partnering with process owners and subject-matter experts to convert procedures, process changes, deviations, CAPAs, and regulatory commitments into effective training; and overseeing the learning management system (such as MasterControl) for data integrity, access, reporting, and change controls.
You will establish standards for instructor-led training, on-the-job training, train-the-trainer programs, knowledge checks, practical demonstrations, and qualification sign-off. You will evaluate training effectiveness using assessments, observation, performance trends, deviation data, audit observations, and stakeholder feedback. You will provide training metrics and risk-based insights to site leadership and governance forums, escalating overdue or ineffective training as appropriate. Supporting internal audits, customer audits, and regulatory inspections by presenting the training system and retrieving supporting records is a critical part of this role.
You will lead, coach, and develop training specialists, coordinators, instructional designers, and qualified trainers. You will manage training vendors, materials, schedules, facilities, and budget within approved requirements. You will promote a culture of continuous learning, quality ownership, and right-first-time execution.
REQUIREMENTS:
- 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, deviations, CAPA, change control, and inspection readiness.
- Experience administering a learning management system and producing reliable compliance reports.
- Demonstrated ability to design, deliver, and evaluate adult learning for technical and procedural content.
- Strong written, verbal, facilitation, project-management, and cross-functional influencing skills.
PREFERRED QUALIFICATIONS:
- Advanced degree or professional certification in instructional design, adult learning, quality, or organizational development.
- Deep familiarity with GMP, GDP, FDA 21 CFR regulations, EU regulations.
- Experience supporting sterile, biologic, solid-dose, active pharmaceutical ingredients, packaging, laboratory, or warehouse operations.
- Experience with electronic document management, quality management, and learning platforms.
- Experience managing direct reports, external vendors, training budgets, or enterprise learning projects.
