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 regulatory requirements related to cGMP.
• Experience managing electronic training systems (e.g., Learning Management System (LMS), Training Management System (TMS)) in a regulated environment.
• Advanced organizational skills, with a keen eye for detail and compliance documentation.
• Strong communication and collaboration skills to work cross-functionally with various departments.
• Familiarity with traditional and modern job training methods and techniques
• Ability to convey complex information in an understandable way

Preferred Skills:

• Previous experience in a quality assurance or training
• Analytical and problem-solving skills to interact with employees, trainers, and other stakeholders
• Knowledge of adult learning principles and instructional design for compliance-based training.
• Experience utilizing Veeva Training.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Work Environment and Physical Demands

• Ability to work hours necessary to support production and/or product transfer activities.
• Occasional interaction with manufacturing and laboratory areas to conduct audits and inspections. May require wearing appropriate personal protective equipment (PPE) such as lab coats, gloves, and safety glasses.
• Frequent interaction with cross-functional teams such as Quality Assurance, Manufacturing, Regulatory Affairs, and senior management.
• May be required to assist with or participate in external regulatory inspections or audits, which could involve coordination across departments.
• Requires extended periods of sitting while working on audits, reports, and data analysis, along with occasional standing during manufacturing floor inspections.
• Must be able to perform tasks that require manual dexterity, such as writing, typing, and handling documents.
• Sustained mental attention to detail, accuracy, and problem-solving during audits, report writing, and compliance reviews.
• Requires good vision (with or without corrective lenses) to review detailed documentation and audit reports, and effective hearing to communicate with team members and external auditors.

Occasional lifting of light objects, such as laptops, files, or small boxes, up to 25 lbs.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Flexible PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to lead