Manager, GMP Training
About the role
The Manager, GMP Training role is located onsite at our Hopewell, NJ site, reporting to the Associate Director, Quality Compliance. BeOne is a rapidly growing company that values passionate professionals with a strong interest in fighting cancer. The role involves leading the site-wide GMP training program, serving as the subject matter expert (SME), and ensuring compliance, effectiveness, and inspection-readiness.
Responsibilities
- 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.
- Able 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.
- 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
Benefits
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.
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 accommodationsus@beonemed.com.