Manager, Training Program

August Bioservices, LLC; Nashville (TN); On-site; USD 110,000 - 140,000; Full time

Job summary

August Bioservices, LLC in Nashville, TN, seeks a Manager of Training to lead the site training program for a pharmaceutical manufacturing organization, ensuring staff are qualified to perform work safely, in compliance with cGMP, procedures, and regulatory requirements.

The role partners with Quality, Operations, Engineering, and HR to build curricula, maintain inspection-ready records, and improve learning effectiveness. Reports to Head of Quality.

Qualifications

• Bachelor’s degree in life sciences, engineering, education, organizational development, business, or related field.
• 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

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; escape 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

Skills

cGMP knowledge

Documentation control

LMS administration

Training design & delivery

Project management

Cross-functional collaboration

Communication

Education

Bachelor’s degree in life sciences, engineering, education, organizational development, business, or related field

Tools

MasterControl

Quality Management Systems

Job description

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 servicesto 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.

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 servicesto 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.

ESSENTIAL DUTIES & 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; escape 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

QUALIFICATIONS

• 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

KNOWLEDGE, SKILLS, & ABILITIES

• 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
• Key Performance Indicator Management
• On-time completion of assigned training and retraining
• Timely qualification for new and transferred employees
• Training-record accuracy and audit readiness
• Effectiveness of curricula, trainers, and qualification methods
• Reduction in recurring errors or deviations linked to knowledge or skill gaps
• Timely completion of training actions arising from changes, CAPAs, and commitments

PHYSICAL REQUIREMENTS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Prolonged periods sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds at times

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. 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.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.