GMP Training Lead & Compliance SME

BeOne Medicines; Hopewell (NJ); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Life Insurance

Paid Time Off

Wellness program

Job summary

BeOne Medicines is seeking a Manager, GMP Training to lead the site-wide GMP training program at the Hopewell, NJ site. You will act as SME for inspections, support eLMS initiatives, and drive governance for GxP training networks, ensuring compliant, effective training. Reports to the Associate Director, Quality Compliance.

You will develop curricula, monitor metrics, and collaborate across functions to ensure timely and compliant training aligned with regulatory expectations.

Qualifications

• Bachelor's degree in Life Sciences or related field with 5+ years in biotech/pharma or regulated manufacturing.
• Experience leading GMP training programs in a regulated environment.
• Strong knowledge of GMP requirements and FDA expectations.
• Experience supporting regulatory inspections and audits.
• Excellent organizational and project management skills.
• Ability to collaborate with employees and leaders at all levels.

Responsibilities

• Lead, maintain, and continuously improve the site GMP Training Program.
• Serve as SME during inspections, audits, and mock inspections.
• Support eLMS planning, testing, and migration.
• Develop and implement Train-the-Trainer program.
• Create curricula and training matrices by site/department/role.
• Drive training compliance and reduce overdue training.
• Establish training governance and role-appropriate training standards.
• Develop training metrics and KPIs to identify risks and improvements.
• Investigate training deviations and CAPAs with cross-functional teams.
• Prepare training reports for management on performance and risks.

Skills

GMP training

Regulatory inspections

Project management

Cross-functional teamwork

Communication

Education

Bachelor's degree in Life Sciences/Quality

Master’s degree (preferred)

Tools

ComplianceWire

Veeva

Smartsheet

Microsoft 365

Job description

BeOne Medicines is seeking a Manager, GMP Training to lead the site-wide GMP training program at the Hopewell, NJ site. You will act as SME for inspections, support eLMS initiatives, and drive governance for GxP training networks, ensuring compliant, effective training. Reports to the Associate Director, Quality Compliance.

You will develop curricula, monitor metrics, and collaborate across functions to ensure timely and compliant training aligned with regulatory expectations.