QMS & Training Specialist

Job summary

The QMS & Training Specialist will be a key member of the Quality Assurance team, responsible for establishing and enhancing the training framework and electronic training system to ensure compliance in a GxP-regulated environment. This role will evolve to encompass broader quality management activities as the organization grows.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, Quality Management, or a related scientific discipline, or equivalent experience.
• Minimum of 5 years of experience in a GxP-regulated pharmaceutical, biotechnology, ATMP, cell therapy, or related life science environment.
• At least 2 years of experience in training management, learning management systems (LMS), or competency management.

Responsibilities

• Develop and manage the GxP training framework and electronic training system in collaboration with the Quality team.
• Work with managers and subject matter experts to create role-based training curricula and competency requirements.
• Monitor training compliance and assist with onboarding and qualification of new employees.
• Contribute to the improvement of the Quality Management System, including handling deviations, CAPAs, change controls, and document management.
• Help design scalable quality and training processes in a growing organization.

Skills

• Strong stakeholder management and collaboration skills.
• Proactive and pragmatic mindset with a focus on continuous improvement.

Education

• Relevant degree in a scientific discipline or equivalent experience.

Tools

• Experience with electronic training management systems and Quality Management Systems.