Manager, GMP Training

BeOne Medicines; Hopewell (NJ); Presencial; USD 80 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Life Insurance

Paid Time Off

Wellness program

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

GMP training

Regulatory inspections

Project management

Cross-functional teamwork

Communication

Formação académica

Bachelor's degree in Life Sciences/Quality

Master’s degree (preferred)

Ferramentas

ComplianceWire

Veeva

Smartsheet

Microsoft 365

Descrição da oferta de emprego

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 ChangeResults-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

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

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

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. 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].