Production Training and Development Manager

Our client, an exciting and growing Bio Sciences firm, is searching for a Production Training and Development Specialist. The Training and development specialist will be 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
Provide constructive feedback and guidance to develop leadership in direct reports and department management
Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

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
Bachelor s 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 environment

• Bachelor s 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 environment
  knowledge of any of the following required: FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP,