GMP Training Specialist

GMP Training Specialist – London – Competitive Package

This role is critical in ensuring that all employees involved inGMP-regulated activitiesreceive the highest standard of training to maintain compliance, product quality, and patient safety.

Key Responsibilities:

• Develop, implement, and maintain aGMP training programtailored for ATMP manufacturing, ensuring compliance with regulatory standards.
• Deliver engaging and effectiveGMP training sessionsfor new hires, operational teams, and senior staff.
• Create and updatetraining materials, SOPs, and competency assessmentsto reflect the latest regulatory changes and best practices.
• Conducttraining gap analysesto identify areas for improvement and ensure continuous enhancement of training programs.
• Maintain accuratetraining recordsin compliance with regulatory expectations (MHRA, FDA, EMA).
• Collaborate withQA, Manufacturing, and Regulatory teamsto align training with quality and compliance objectives.
• Prepare the organization forregulatory inspections, ensuring employees are audit-ready regarding GMP training compliance.
• Supporton-the-job training initiatives, working closely with team leaders and subject matter experts to reinforce best practices.

Requirements:

• Experience inGMP training and compliancewithin apharmaceutical or biotechnologyenvironment, preferably inATMPs, cell & gene therapy, or biologics.
• Strong knowledge ofGMP regulations(MHRA, FDA, EMA, ICH, Eudralex) and training best practices.
• Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences.
• Experience withLearning Management Systems (LMS)and electronic training records is a plus.
• A proactive mindset, with strong attention to detail and organizational skills.

What is in it for you?

• Be part of a groundbreaking biopharmaceutical company that is transforming patient care.
• Work in a dynamic ATMPenvironment, contributing to cutting-edge therapies.
• Competitive salary and benefits package, with opportunities for career growth.
• A supportive and collaborative team culture.

🚀Apply nowand take the next step in your GMP training career with an exciting ATMP company!