Job Description
Job DescriptionSalary:
Purpose
The Training Manager is responsible for the strategic development, implementation, and oversight of the organization's training program in accordance with FDA 21 CFR 1271, AATB standards, and internal policies governing the recovery, processing, and distribution of human tissue for transplantation. This position ensures that all personnel are adequately trained, qualified, and competent to perform assigned duties within a regulated tissue banking environment.
Responsibilities
- Develop, implement, and maintain a comprehensive training program for all Production staff, including initial, ongoing, and competency-based training
- Ensure training programs are compliant with applicable regulations, standards, and organizational requirements (FDA 21 CFR 1271, AATB, state regulations, and internal SOPs)
- Oversee the creation, revision, and delivery of training materials, including classroom sessions, competency assessments, on-the-job training (OJT), and e-learning modules
- Partner with department leaders and subject matter experts (SMEs) to identify training needs and support departmental-specific training initiatives
- Maintain accurate and current training records for all staff in accordance with regulatory requirements
- Lead training audits and readiness activities, ensuring that all training documentation and processes are inspection ready
- Support corrective and preventive actions (CAPA) and deviation investigations by addressing training-related issues and implementing appropriate training interventions
- Monitor the effectiveness of training programs through metrics, evaluations, and continuous improvement initiatives
- Ensure new hire onboarding and orientation programs are effectively executed and tailored for Production roles in processing and support
- Provide leadership, coaching, and development opportunities for Training Department staff (if applicable)
- Stay current on changes in regulations, standards, and industry best practices related to training and tissue banking operations
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
- Manage direct reports (if applicable)
- Provide constructive feedback and guidance to develop leadership in direct reports and department management
- Establish and monitor objective annual goals for direct reports
- Conduct performance reviews and establish performance improvement plans as needed
- Recruit, interview, and select personnel for hire
- Travel domestically up to 10% to attend offsite meetings, conferences, and support business initiatives
- Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes
- Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary
- Perform other duties as assigned
Skills
- Exceptional organizational and project management skills
- Strong written and verbal communication skills, including the ability to deliver training content effectively to diverse audiences
- Ability to collaborate across departments and influence positive training outcomes
- Analytical mindset with a focus on continuous improvement
- Ability to work independently and in a team environment
- Excellent attention to detail and organization
- Excellent written and verbal communication
- Ability to multi-task and work in a fast-paced environment
- Strong technical writing
- Proficiency in Microsoft Office
Qualifications/Requirements
- Bachelors degree in Life Sciences, Healthcare Administration, Organizational Development, or a related field
- An equivalent combination of education and experience may be considered
- Minimum of 3-5 years of experience in a regulated healthcare, tissue banking, pharmaceutical, or biotech environment
- Experience developing, implementing, and maintaining training programs in a cGMP/cGTP-regulated setting preferred
- Strong understanding of FDA 21 CFR 1271, AATB Standards, and regulatory training documentation requirements
- Clearance of favorable background investigation required