Manager, Training Program

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