Manager, Training Program

August Bioservices • Nashville, TN

1d • Onsite

About The Position

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.

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.

Nice To Haves

• 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.
• Quality and compliance mindset
• Strategic planning and disciplined execution
• Clear communication and facilitation
• Coaching and talent development
• Sound judgment and risk-based decision-making
• Collaboration and stakeholder management

Responsibilities

• 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; escalate overdue or ineffective training as appropriate. LMS administration which oversees eQMS for tracking training (e.g., MasterControl).
• 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.

Benefits

• We believe in the promise of discovery and the power of science to transform lives.
• We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement.
• We aspire to unlock the potential in every person, every process and every molecule – from start to finish.
• We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements.
• We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager