Senior Manager, Global GxP Training

Beam Therapeutics; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Beam Therapeutics seeks a Senior Manager, Compliance and Training to design and execute global training programs aligned with Beam's Global Quality Policies and Standards. The role ensures GMP/GXP compliance training, maintains Quality Management System documents, and provides system training expertise across Beam's Quality Systems.

This position reports to the Senior Director, Quality Systems and Compliance and is on-site three days a week.

Qualifications

• University degree in Life Sciences or equivalent experience.
• 10+ years in GMP/GXP with 3+ years in training oversight.
• Knowledge of regulatory requirements in pharma/biotech.
• Strong communication, negotiation, and interpersonal skills.
• Ability to work independently and manage multiple projects.
• Experience with Quality Systems, Document Management Systems, and Learning Management Systems.
• Technical writing experience.
• Detail-oriented and collaborative.
• Knowledge of risk management and root cause analysis.
• Ability to design and implement training initiatives.

Responsibilities

• Develops, leads, and implements training initiatives aligned with business strategies.
• Designs, develops, and delivers instructional materials (digital and physical).
• Manages the performance/effectiveness of quality system training programs.
• Supports GXP digital landscape and best practices for electronic quality training systems.
• Assists in refining system user training and training delivery.
• Maintains Beam's Quality Management System policies and procedures with regulatory changes.
• Develops user requirements for Quality training systems and supports validation deliverables.
• Contributes to test script generation/review/approval for computer systems.
• Supports site/audit preparations related to system functionality.
• Develops streamlined processes and Work Instructions for Quality Systems.
• Maintains system-related metrics and analyzes training effectiveness.
• Owns Quality Events (Issues, Change Controls, CAPAs) per procedures.
• Provides QA guidance to stakeholders.

Skills

Interpersonal communication

Negotiation skills

Independence & self-motivation

Training design & delivery

Risk management & root cause analysis

Technical writing

Detail-oriented

Cross-functional collaboration

GMP/GXP environment experience

Education

University degree in Life Sciences or equivalent experience

Tools

Quality Management Systems

Document Management Systems

Learning Management Systems

Microsoft Office (Word, Excel)

Job description

Beam Therapeutics seeks a Senior Manager, Compliance and Training to design and execute global training programs aligned with Beam's Global Quality Policies and Standards. The role ensures GMP/GXP compliance training, maintains Quality Management System documents, and provides system training expertise across Beam's Quality Systems.

This position reports to the Senior Director, Quality Systems and Compliance and is on-site three days a week.