GMP Training Manager: Compliance & eLMS Lead

BeOne Medicines Ltd.; Pennington (NJ); Sur place; USD 90 000 - 140 000; Plein temps

Résumé du poste

BeOne Medicines Ltd. seeks a Manager, GMP Training to lead the site-wide GMP training program at the Hopewell, NJ facility, ensuring compliance, inspection readiness, and effective learning.

You will act as SME for regulatory inspections, support the eLMS rollout, develop curricula, and drive training governance and metrics to continually improve training performance. Collaborate with QA, manufacturing, and regulatory affairs to address deviations, CAPAs, and training gaps.

Qualifications

• 5+ years of GMP training experience in biotech/pharma or regulated manufacturing.
• Experience leading GMP training programs in a regulated environment.
• Knowledge of GMP requirements and FDA expectations.

Responsabilités

• Lead, maintain, and improve the site GMP training program.
• Support eLMS implementation, testing, and migration.
• Develop and implement a Train-the-Trainer program.
• Create curricula and training matrices by site/department/role.
• Collaborate to improve training compliance and reduce overdue training.
• Prepare training reports and management-level presentations.

Connaissances

GMP Training

Regulatory Inspections

eLMS Implementation

Curriculum Development

Training Metrics

Cross-functional Collaboration

Project Management

Veeva

Smartsheet

MS 365

Formation

Bachelor's degree in Life Sciences or related field

Master’s degree (preferred)

Outils

ComplianceWire

Veeva

Smartsheet

Microsoft 365

Description du poste

BeOne Medicines Ltd. seeks a Manager, GMP Training to lead the site-wide GMP training program at the Hopewell, NJ facility, ensuring compliance, inspection readiness, and effective learning.

You will act as SME for regulatory inspections, support the eLMS rollout, develop curricula, and drive training governance and metrics to continually improve training performance. Collaborate with QA, manufacturing, and regulatory affairs to address deviations, CAPAs, and training gaps.