GMP Training Program Lead

BeiGene, Ltd.; New Jersey; Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Job summary

BeOne is a global oncology company seeking a Manager, GMP Training at our Hopewell, NJ site. You will lead the site-wide GMP training program as SME, ensure inspections readiness, and act as the site BPL for global GxP training networks and eLMS initiatives.

The role requires a life sciences or related degree with 5+ years in biotech or regulated manufacturing, experience in GMP training, and strong collaboration and project management skills.

Qualifications

• Bachelor’s degree with 5+ years in biotech/pharma or regulated manufacturing required; Master’s degree preferred.
• Experience leading GMP training programs in a regulated environment.
• Strong knowledge of GMP, FDA expectations, and quality systems.
• Experience supporting regulatory inspections, audits, and inspection readiness.

Responsibilities

• Lead, maintain, and continuously improve the site GMP Training Program.
• Serve as SME during regulatory inspections, audits, and mock inspections.
• Support eLMS implementation, upgrades, testing and migration.
• Develop and implement a Train-the-Trainer Program.
• Develop curricula and training matrices for site/department/roles.

Skills

GMP training program management

Regulatory inspections support

Training analytics

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Quality, Education, Business, or related field

Master’s degree in related field

Tools

ComplianceWire

Veeva

Smartsheet

Microsoft 365 (Excel, PowerPoint, Word, Outlook, Teams, SharePoint)

Job description

BeOne is a global oncology company seeking a Manager, GMP Training at our Hopewell, NJ site. You will lead the site-wide GMP training program as SME, ensure inspections readiness, and act as the site BPL for global GxP training networks and eLMS initiatives.

The role requires a life sciences or related degree with 5+ years in biotech or regulated manufacturing, experience in GMP training, and strong collaboration and project management skills.