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Manager, Training Program

August Bioservices
Nashville, USA
Full-time
Manager · 2+ years experience
Onsite
Discovered 1 weeks ago

Full Job Posting

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

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.

Additional information

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.

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