GMP Training Program Lead & Compliance SME

BeiGene; Hopewell (VA); On-site; USD 80,000 - 110,000; Full time

Job summary

BeOne Medicines Ltd. seeks a Manager, GMP Training to lead the site-wide GMP training program and ensure compliance, readiness for inspections, and effective execution of training strategies. The role also acts as the site BPL for global GxP training networks and eLMS initiatives.

The position is onsite at the Hopewell, NJ site and reports to the Associate Director, Quality Compliance. Candidates should have extensive GMP training program experience and strong collaboration skills.

Qualifications

• Bachelor’s or higher in Life Sciences, Quality or related field with GMP training program experience.
• Experience supporting regulatory inspections and audits in a regulated setting.
• Strong knowledge of GMP requirements and quality systems.

Responsibilities

• Lead, maintain, and improve the site GMP Training Program aligned with procedures and regulatory expectations.
• Serve as SME during inspections, audits, and mock inspections.
• Support eLMS implementation, planning, testing and migration.
• Develop and implement Train-the-Trainer programs.
• Develop curricula and training matrices by site/department/role.
• Improve training compliance and reduce overdue training.
• Establish and maintain training governance and metrics.
• Collaborate with functions to address deviations, CAPAs, and gaps.
• Prepare training reports and management presentations.

Skills

GMP training management

Regulatory inspections support

eLMS implementation

Curriculum development

Cross-functional collaboration

Project management

Education

Bachelor's degree in Life Sciences or related

Master's degree preferred

Tools

ComplianceWire

Veeva

Smartsheet

Microsoft 365

Job description

BeOne Medicines Ltd. seeks a Manager, GMP Training to lead the site-wide GMP training program and ensure compliance, readiness for inspections, and effective execution of training strategies. The role also acts as the site BPL for global GxP training networks and eLMS initiatives.

The position is onsite at the Hopewell, NJ site and reports to the Associate Director, Quality Compliance. Candidates should have extensive GMP training program experience and strong collaboration skills.