GxP Training Manager

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverantpersevering idealists. We need the best-in-class. In other words, we need you :you: The ‘make-it-happener’.

We are looking for a hands-on GxP Training Manager - Princeton, NJ, US

Scope of the job

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.

Your role

Training Program Development

• 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.

Implementation & Delivery:

• 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.

Continuous Improvement

• 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.

Quality Management Systems Operations (20-30%):

• 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

Education and Experience:

• 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).

Skills and Competencies:

• Strong presentation and facilitation skills, with the ability to engage and train diverse audiences.

• Excellent organizational and project management skills.

• Strong interpersonal and communication skills, both written and verbal.

• Ability to work collaboratively with cross-functional teams.

• Proficiency with Microsoft Office and LMS platforms.

• Knowledge of GxP regulations advantageous

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job. 

We are Galapagos: together we can make it happen…!

Base compensation for this position ranges from $ 106,875 to $ 178,125 Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.