GxP Training Manager

Galapagos • Princeton, NJ

256d • $106,875 - $178,125

About The Position

The GxP Training Manager will be responsible for designing, developing, and implementing a comprehensive GxP (Good Practice) training program and matrix to ensure compliance with regulatory standards (e.g., FDA, EMA) for Galapagos. This role will oversee training on all regulated processes within the business, have business ownership of the learning management system and lead LMS administration. Additional responsibilities include operational support for wider QMS processes, with a focus on US users.

Requirements

• Bachelor's degree in Life Sciences, Quality Management, or a related field.
• Minimum of 5 years of experience in regulated environments.
• Proven experience in developing and managing training programs, preferably in a regulated function.
• Experience with e-learning tools (articulate storyline) and Learning Management Systems (Veeva Vault Training).

Nice To Haves

• Knowledge of GxP regulations advantageous.

Responsibilities

• Design and maintain a comprehensive and effective GxP training program covering GMP, GCP, GLP, and other relevant regulatory requirements.
• Design and develop role-specific training modules, including both onboarding and continuing education programs for employees across different departments.
• Ensure training materials are current with evolving regulatory standards and internal policies.
• Support training matrix management.
• Manage the implementation of the training program through the LMS.
• Facilitate and deliver GxP training sessions in various formats (in-person, online, webinars, etc.).
• Collaborate with subject matter experts to develop technical training content and ensure accuracy.
• Organize and coordinate training schedules for new hires and ongoing employee development.
• Lead the Galapagos Trainer Qualification program.
• Monitor and assess training effectiveness through employee feedback, assessments, and audits, continuously improving training content and delivery.
• Stay up to date with industry trends and best practices in GxP training and compliance.
• Audit and Inspection support as required.
• Workflow management for QMS processes.
• Documentation and training administration.
• Create and maintain metrics and dashboards; provide reports on demand.
• User support and issue management.

Benefits

• Competitive compensation package.
• Supportive work environment with a strong focus on health and well-being.
• Opportunities for continuous growth and development.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree