Manager, GMP Training

BeiGene, Ltd.; New Jersey; Vor Ort; USD 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Medical

Dental

Vision

401(k)

FSA/HSA

Life Insurance

Paid Time Off

Wellness

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP training program management

Regulatory inspections support

Training analytics

Cross-functional collaboration

Ausbildung

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)

Jobbeschreibung

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

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.

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

Salary Range: $79,600.00 - $109,600.00 annually.

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

We are proud to be an equal opportunity employer.

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

All employment is decided on the basis of qualifications, merit, and business need.

Accommodation Request

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [e-mail].

About BeOne

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.

Values

• Patients First
• Driving Excellence
• Bold Ingenuity
• Collaborative Spirit