Position Summary:

The Manager, Training & Development BioCenters leads, mentors, develops, implements, administers, and continuously improves the training program for ADMA Biologics. This role is responsible for ensuring the training program is fully implemented at all levels of the organization.

Essential Functions and Responsibilities:

• Promote a culture of quality and operational excellence and ensure the advancement of the Company’s mission and values.
• Maintain thorough understanding of the role and responsibilities and perform duties in compliance with CFR, SOPs, cGMPs, OSHA, Safety regulations, and other rules and regulations, as applicable.
• Able to understand complex regulations and SOPs and transfer the information into tailored training materials.
• Maintains confidentiality of all personnel, donor, and center information.
• Attends center management meetings as a training representative and actively participates in problem-solving sessions.
• Utilize adult learning principles to design, create, and develop learning solutions to meet learning objectives and accommodate a variety of learning styles.
• Develop and deliver engaging learning solutions that produce the desired outcomes in responding to the learners needs, including hybrid and virtual learning through a variety of media (i.e., videos, PowerPoints, demonstrations, etc.).
• Lead the Training department’s team members in critical thinking problem solving.
• Create and facilitate training and development, learning initiatives, and training curriculum for specific roles and departments.
• Perform gap analysis to identify opportunities to continuously improve the training program and evaluate effectiveness of training programs to address areas of deficiency (as needed).
• Review and improve SOPs and training programs used across the organization.
• Assist other functional areas in developing training materials associated with departmental SOPs and policies.
• Coordinate and lead cGMP training program, and other annual trainings, ensuring all employees receive required training, including instructor led training.
• Participate in development of training metrics to maintain compliance.

Education & Experience Requirements:

Education Requirements:

• Bachelor’s degree in Education with a training and development focus.

Experience Requirements: 

• Minimum of 5-7 years’ experience in a Manufacturing, Compliance, Quality Assurance, Quality Control, or Healthcare environment with at least 2 years leading training initiatives and continuous improvement in an FDA-regulated environment.

Travel Requirement: This role will be based in Boca Raton, Florida, and will require up to 75% of travel to the BioCenters.

Preferred Education & Experience:

Preferred Education: Master’s degree preferred.

Preferred Experience: 

• Experience in Camtasia, Adobe Premiere Pro, iMovie, and WellSaid Labs.
• Detail-oriented with expert Microsoft Office skills, including Word, Excel, Project, Visio, and PowerPoint.
• Proficiency in Learning Management Systems (LMS) or electronic Quality Management Systems (eQMS) administration such as Soft Expert.
• Knowledge of FDA regulations for the pharmaceutical industry.

Compliance Requirements:

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.