Director GxP Training and Knowledge Management

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden.  For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.  At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.  Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands.  We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 

This position is site-based and requires a presence on-site three-four days per week. 

Summary of role

The Director GxP Training and Knowledge Management will have responsibility for developing and executing Lantheus Holdings, Inc.’s (LH) corporate GxP learning strategy and training program. This role is responsible for the development and delivery of the training strategy, training matrices/plans, training materials, requirements, and curricula using adult learning principles and techniques, content development tools, virtual and blended learning models, and learning analytical tools required to implement enhanced learning and ensuring competency requirements are met. As the process owner for training, this position is also responsible for driving organization-wide GxP training initiatives and building a training infrastructure to support Lantheus’ continued growth. This role will closely interact with cross-functional colleagues, potentially across multiple sites.

Key Responsibilities/Essential Functions

· Responsible for developing, owning and executing a scalable training strategy and training matrices/plans across all GxP areas for the organization that supports current business and future growth of Lantheus.

· Leads the development of a unified role-based approach to training matrices/plans, curriculum design, learning analytics, and performance metrics. Works closely with cross-functional leaders to drive development and optimization of non GxP training curriculums.

· Designs, develops, facilitates and/or delivers general site and technical training content, including instructional tools, hands-on exercises, exams and certifications. Evaluates training needs and

participates in the acquisition or development of training materials. Follows and adopts relevant training development industry trends and best practices.

· Collaborates with functional areas to develop employee training requirements, develop training materials and knowledge assessments, with a focus on reducing the door-to-floor training of new employees.

· Routinely delivers various cGMP training sessions (in-person or virtual) for new and existing employees, focusing on specific SOPs, equipment, change controls and documentation for at cause issues or part of on-going training.

· Assists GxP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs and certifications, including new hire GxP training for all employees.

· Assesses need for training requirements on new documents or processes and collaborates with document owner(s) or Subject Matter Experts to implement requirements.

· Responsible for the overall administration of the training system at Lantheus, ensuring GxP training records are maintained, secure, and retrievable throughout defined retention cycles.

· Provides oversight and leadership of the training program; is the subject matter expert, provides training/support to system users. Collaborates with IT to resolve issues and implement enhancements.

· Develops training performance metrics, tracks status of training requirements and reports to management periodically or as requested.

· Analyzes process effectiveness, identifies enhancements, and actively drives continuous improvement of training programs and processes. Consistently solicits employee feedback and establishes clear and measurable success factors to demonstrate sustainable impact.

· Represents the site training function during management reviews and audits, as necessary.

· Other duties as assigned.

Basic Qualifications

· Bachelor’s degree and 10+ years of experience as a trainer in pharma/biotech manufacturing, or similar regulated environment.

· Direct experience in developing and designing courses, training matrices/plans, and effective delivery strategies, inc