Head of Quality/GMP Training

About Forge:

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

 

About The Role: 

The Director, cGMP Operations Training role will have extensive experience in a cGMP-regulated environment, with a strong understanding of FDA, EMA, and other regulatory requirements. They should possess a proven track record of managing training systems and developing compliance-based training programs, preferably in the biotech or pharmaceutical industry. Strong organizational, communication, and data analysis skills are essential, along with the ability to collaborate across departments and manage audit-ready training documentation.

 

What You'll Do:

The Director, cGMP Operations Training is responsible for managing and maintaining the training programs and systems within operational and quality departments to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory standards. This role focuses on the development, implementation, and oversight of training initiatives, managing the training management system (i.e., Veeva Training), and ensuring that all employees meet required certifications and compliance requirements. The Director, cGMP Operations Training also collaborates with department heads to review training plans, analyze training data, address gaps or non-compliance, and prepare for audits and inspections.

• Training Program Development: Design, implement, and manage robust training programs specific to cGMP requirements, focusing on compliance, quality assurance, and regulatory standards.
• Training System Management: Oversee the electronic Training Management System (TMS) (i.e., Veeva Training) to ensure all employees in regulated departments are trained, tracked, and up-to-date with required training requirements and certifications. Ensure the TMS accurately tracks employee training completion, certifications, and compliance status across all operational and quality departments.
• Trending and Reporting: Regularly analyze training data to identify trends, gaps, or areas of non-compliance, generating reports to inform leadership and support continuous improvement.
• Training Actions: Through collaboration with Quality, implement and monitor corrective remedial training actions identified through findings, ensuring compliance is maintained.
• Collaboration: Partner with department heads (Manufacturing, QA, QC, Regulatory, etc.) to identify training needs, ensure curriculum alignment, and develop training plans for new hires, ongoing certifications, and role-based compliance.
• Training Plan Reviews: Collaborate with department heads to review and update individual and department-level training plans, ensuring they remain aligned with regulatory requirements and operational changes.
• Compliance Audits & Documentation: Ensure all training records meet regulatory requirements, prepare for internal and external audits, and maintain accurate documentation of training activities.
• Subject Matter Expert (SME) Management: Work with internal SMEs to ensure technical and compliance expertise is incorporated into training modules.
• Continuous Improvement: Regularly assess and enhance training effectiveness through feedback, audits, and performance evaluations, ensuring training programs evolve with regulatory and operational changes.

What You'll Bring:

• Bachelor’s degree in Life Sciences, Biotechnology, or a related field (advanced degree preferred).
• 10+ years of experience in a cGMP environment, preferably in training management within the biotech, pharmaceutical, or life sciences industry.
• Strong understanding of FDA, EMA, and other regul