The Role
Leads the pharmaceutical manufacturing site training program, ensuring employees and contractors are qualified, compliant, and inspection-ready. Oversees curricula, training records, LMS and eQMS administration, instructor standards, qualification pathways, effectiveness assessments, metrics, audits, vendors, budgets, and continuous improvement. Partners cross-functionally with Quality, Operations, Engineering, EHS, Human Resources, and subject-matter experts. Manages and develops training personnel while supporting cGMP, regulatory, deviation, CAPA, and change-control requirements.
Summary Generated by Built In
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.
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; 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.
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
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 25 pounds at times.
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.
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.
Skills Required
- 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.
- At least two years of experience 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.
- Ability to design, deliver, and evaluate adult learning for technical and procedural content.
- Strong written, verbal, facilitation, project-management, and cross-functional influencing skills.
- Advanced degree or professional certification in instructional design, adult learning, quality, or organizational development.
- Familiarity with GMP, GDP, FDA 21 CFR regulations, and EU regulations.
- Experience supporting sterile, biologic, solid-dose, active pharmaceutical ingredient, 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.
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The Company
What We Do
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.
