Manager, GMP Training

BeOne Medicines; Pennington (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

BeOne Medicines in Hopewell, NJ is seeking a Manager of GMP Training to lead the site-wide GMP training program and serve as the SME for regulatory inspections. The role also drives eLMS initiatives and trains a Train-the-Trainer program to ensure compliant, effective learning across the site.

Reporting to Quality Compliance, the role requires a Bachelor’s in Life Sciences or related field with 5+ years in GMP training, with a Master’s preferred. Onsite work at the Hopewell site is expected.

Qualifications

• Bachelor's degree in Life Sciences, Quality, Education, Business, or related field with 5+ years of biotechnology/pharmaceutical or regulated manufacturing experience including GMP training program management.
• Master’s degree and 4+ years of related experience preferred.
• Experience leading GMP training programs in a regulated manufacturing environment.
• Strong knowledge of GMP requirements, FDA expectations, and quality systems.
• Experience supporting regulatory inspections, audits, and inspection readiness.
• Knowledge of training effectiveness assessments and risk-based training strategies.
• Experience managing training through major organizational, process, system, or facility changes.
• Excellent organizational, analytical, communication, and project management skills.
• Ability to collaborate effectively with employees and leaders across all organizational levels.
• Strong attention to detail, customer focus, and ability to manage competing priorities and time-sensitive compliance issues.

Responsibilities

• Lead, maintain, and continuously improve the site GMP Training Program in alignment with procedures and regulatory expectations.
• Serve as SME during regulatory inspections, internal audits, and mock inspections.
• Support eLMS implementation and upgrades including planning, testing, and migration.
• Develop and implement a Train-the-Trainer Program.
• Develop and maintain curricula and training matrices at multiple levels.
• Lead cross-functional efforts to improve training compliance and reduce overdue training.
• Establish and maintain training governance to ensure role-appropriate training.
• Develop training metrics and KPIs to identify trends and risks.
• Collaborate with functional areas to address deviations, CAPAs, and audit findings.
• Prepare training reports and management-level presentations.

Skills

GMP training management

Regulatory inspections readiness

Cross-functional collaboration

Project management

Analytical skills

Communication skills

Education

Bachelor's degree in Life Sciences or related field

Master’s degree preferred

Tools

ComplianceWire

Veeva

Smartsheet

Microsoft 365

Job description

General Description:

The Manager, GMP Training is responsible for leading the site-wide GMP training program, serving as the subject matter expert (SME), and ensuring that the training program remains compliant, effective, and inspection-ready.

The incumbent also functions as the site Business Process Lead (BPL) for global GxP training networks, governance forums, electronic Learning Management System (eLMS) initiatives, and harmonization projects, translating global strategies into actionable site-level implementation plans.

This role is located onsite at our Hopewell, NJ site, reporting to the Associate Director, Quality Compliance.

Essential Functions of the Job:

• Lead, maintain, and continuously improve the site GMP Training Program in alignment with company procedures, regulatory expectations, site objectives, and operational needs.

• Serve as SME during regulatory inspections, internal audits, and mock inspection activities.

• Support eLMS implementation and upgrades, including planning, testing and migration.

• Develop and implement a Train-the-Trainer Program.

• Develop and maintain site-, department-, role-, task-, and qualification-based curricula and associated training matrices.

• Lead cross-functional efforts to improve training compliance, reduce overdue training, and enhance overall training effectiveness.

• Establish and maintain training strategies, processes, and governance to ensure employees receive role-appropriate training.

• Develop and monitor training metrics and key performance indicators to identify trends, risks, and improvement opportunities.

• Collaborate with functional areas to investigate training-related deviations, CAPAs, audit observations, and compliance gaps, and ensure appropriate corrective actions are implemented.

• Set standards for training content, effectiveness assessments, and qualification activities.

• Prepare training reports and management-level presentations that communicate program performance, compliance status, and emerging risks.

• Perform other duties as assigned by management.

Qualifications:

• Bachelor's degree in Life Sciences, Quality, Education, Business, or related field with 5+ years of experience in the biotechnology, pharmaceutical, or regulated manufacturing industry, including experience managing GMP training programs required; Master’s degree and 4+ years of related experience preferred.

• Experience leading or managing a GMP training program in a regulated manufacturing environment.

• Strong knowledge of GMP requirements, FDA expectations, and quality systems.

• Experience supporting regulatory inspections, audits, and inspection readiness efforts.

• Knowledge of training effectiveness assessments and risk-based training strategies.

• Experience managing training through major organizational, process, system, or facility changes.

• Excellent organizational, analytical, communication, and project management skills.

• Ability to collaborate effectively with employees and leaders across all organizational levels.

• Strong attention to detail, customer focus, and ability to manage competing priorities and time-sensitive compliance issues.

Computer Skills:

• Extensive experience with a validated eLMS, preferably ComplianceWire.

• Experience electronic document management system, preferably Veeva.

• Advanced proficiency with Smartsheet, Microsoft 365, including, Excel, PowerPoint, Word, Outlook, Teams, and SharePoint.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.