Manager, Training & Development

Manager, Training & Development

The Manager, Training and Development will lead, mentor, develop, implement, administer, and continuously improve the training program for the company. This position will be responsible for ensuring the training program is fully implemented at all levels of the organization.

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.
• Provide feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
• Oversee job-specific departmental training to ensure program appropriateness and compliance. Assess programs for effectiveness and initiate improvement plans where necessary.
• Act as a Training SME for all employees at all levels of the organization.
• Coordinate and perform any additional activities or projects assigned.
• Act as a mentor for new hires and trainees alike including peers.
• Lead initiatives in improving training programs across the company including but not limited to corporate, business and manufacturing areas.
• Lead by example and act as a role model for setting the standard within the Training Department.
• Act as team lead in the absence of Senior Manager or Training Director.
• People manage as guided by Senior Manager and above.
• Provide continuous development for all Training department team members, including providing feedback when necessary.
• Oversee the training program for the BioCenters.
• Develop, implement, and maintain a robust training program for preceptors and Training Coordinators.
• Work with center leadership and Training Coordinators to identify, train and assign preceptors as needed to ensure the competency of center staff.
• Ensure the annual competency evaluations of center staff occur timely, is an accurate determination of performance, and is executed correctly.
• Develop and implement performance evaluations to ensure staff are competent on daily job responsibilities.
• Ensure training records are being maintained and accurate at all times as a part of inspection readiness.
• Work closely with Quality Assurance (QA) and leadership to determine training and re-training needs.
• Communicates regularly with leadership on the status of training activities.
• Responsible for the successful completion of New Hire Orientation (NHO) across the organization.
• Maintain the eQMS as a training lead.

Qualifications

• Bachelor’s degree in Education or Scientific Discipline with a training and development focus.
• Minimum of 5-7 years’ experience in 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.
• Managerial experience required
• Camtasia, Adobe Premiere Pro, iMovie, and WellSaid Labs experience preferred
• Detail-oriented with expert Microsoft Office skills, including Word, Excel, Project, Visio, and PowerPoint preferred
• Proficiency in Learning Management Systems (LMS) or electronic Quality Management Systems (eQMS) administration such as Soft Expert preferred
• Knowledge of FDA regulations for the pharmaceutical industry preferred
• Travel: Up to 75% travel is required (mostly Southeast)