GMP Training Program Lead - Inspection-Ready Compliance

BeiGene, Ltd.; United States; On-site; 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 seeking a Manager, GMP Training at the Hopewell, NJ site to lead the site-wide GMP training program, act as SME, and ensure compliance and inspection readiness. The role reports to the Associate Director, Quality Compliance.

You will develop curricula, maintain training matrices, monitor metrics, support eLMS initiatives, and collaborate across functions to improve training effectiveness and readiness for audits.

Qualifications

• Bachelor's degree with 5+ years of GMP training program experience.
• Experience leading GMP training in regulated manufacturing environments.
• Strong knowledge of GMP requirements, 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, internal audits, and mock inspections.
• Support eLMS implementation and upgrades, planning, testing and migration.
• Develop and implement a Train-the-Trainer Program.
• Develop and maintain curricula and training matrices.
• Lead cross-functional efforts to improve training compliance and effectiveness.
• Establish training governance and monitor KPIs to identify risks.
• Prepare training reports and management-level presentations.

Skills

Organizational skills

Analytical skills

Communication skills

Project management

Education

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

Master’s degree

Tools

ComplianceWire

Veeva

Smartsheet

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

Job description

BeOne is seeking a Manager, GMP Training at the Hopewell, NJ site to lead the site-wide GMP training program, act as SME, and ensure compliance and inspection readiness. The role reports to the Associate Director, Quality Compliance.

You will develop curricula, maintain training matrices, monitor metrics, support eLMS initiatives, and collaborate across functions to improve training effectiveness and readiness for audits.