Manager of Training Excellence (Pharma Ops)

August Bioservices LLC; Nashville (TN); Presencial; USD 110.000 - 170.000; Jornada completa

Descripción de la vacante

August Bioservices LLC in Nashville, TN is seeking a Manager of Training to lead the site’s training program, ensuring employees and contractors are qualified to perform work safely, consistently, and in compliance with cGMP and regulatory requirements.

You will partner with Quality, Operations, Technical Services, Engineering, EHS, and HR to build role-based curricula, maintain inspection-ready records, and improve learning effectiveness. Report to Head of Quality.

Formación

• Bachelor’s degree in life sciences, engineering, education, organizational development, or related field.
• 5+ years in regulated pharma/biotech manufacturing with at least 2 years in training or leadership.
• Working knowledge of cGMP, 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.

Responsabilidades

• 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; elevate 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.

Conocimientos

Instructional design

cGMP knowledge

LMS administration

Training leadership

Cross-functional collaboration

Educación

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

Advanced degree or professional certification in instructional design/quality

Herramientas

MasterControl LMS

eQMS software

Descripción del empleo

August Bioservices LLC in Nashville, TN is seeking a Manager of Training to lead the site’s training program, ensuring employees and contractors are qualified to perform work safely, consistently, and in compliance with cGMP and regulatory requirements.

You will partner with Quality, Operations, Technical Services, Engineering, EHS, and HR to build role-based curricula, maintain inspection-ready records, and improve learning effectiveness. Report to Head of Quality.