GMP Training Specialist – London – Competitive Package

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

Key Responsibilities:

• Develop, implement, and maintain a GMP training program tailored for ATMP manufacturing, ensuring compliance with regulatory standards.
• Deliver engaging and effective GMP training sessions for new hires, operational teams, and senior staff.
• Create and update training materials, SOPs, and competency assessments to reflect the latest regulatory changes and best practices.
• Conduct training gap analyses to identify areas for improvement and ensure continuous enhancement of training programs.
• Maintain accurate training records in compliance with regulatory expectations (MHRA, FDA, EMA).
• Collaborate with QA, Manufacturing, and Regulatory teams to align training with quality and compliance objectives.
• Prepare the organization for regulatory inspections, ensuring employees are audit-ready regarding GMP training compliance.
• Support on-the-job training initiatives, working closely with team leaders and subject matter experts to reinforce best practices.

Requirements:

• Experience in GMP training and compliance within a pharmaceutical or biotechnology environment, preferably in ATMPs, cell & gene therapy, or biologics.
• Strong knowledge of GMP regulations (MHRA, FDA, EMA, ICH, Eudralex) and training best practices.
• Excellent presentation, communication, and interpersonal skills, with the ability to engage diverse audiences.
• Experience with Learning 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 ATMP environment, contributing to cutting-edge therapies.
• Competitive salary and benefits package, with opportunities for career growth.
• A supportive and collaborative team culture.

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