Specialist, Compliance

Position Summary

We are seeking a highly skilled Compliance Specialist to support site learning and training compliance programs, ensuring adherence to Quality Management System (QMS) requirements, regulatory expectations, and global standards. This role will support training compliance, instructional design, and continuous improvement initiatives to maintain an effective and inspection-ready learning environment. The ideal candidate brings experience in GxP compliance, instructional design, performance consulting, Learning Management System (LMS) activities & curriculum management.

This role partners with Subject Matter Experts (SMEs), Quality, business stakeholders, and L&D colleagues to translate business and compliance needs into effective learning solutions.

• Design, develop, update, and sustain instructor‑led training, job aids, eLearning modules, and other learning solutions aligned with adult learning principles, business needs, quality & regulatory expectations, and site standards.
• Partner with SMEs, Quality, business stakeholders, and L&D colleagues to assess needs, define learning objectives, identify performance gaps, and recommend targeted solutions.
• Review and improve learning content for accuracy, relevance, engagement, accessibility, and compliance with approved standards.
• Execute LMS and curriculum management activities, including training assignments, learning artifact updates, curriculum accuracy checks, learner population alignment, and deployment support.
• Use digital tools and learning technologies to improve learner experience, workflow efficiency, and scalable training delivery.
• Manage deliverables, communicate status, risks, dependencies, and decisions needed, and drive timely completion of assigned work.
• Provide flexible support, including off‑shift coverage as needed, to meet production floor training needs and support timely employee qualification.
• Evaluate training effectiveness using available data, feedback, observations, and performance indicators, and recommend continuous improvement actions.

• Experience with Articulate 360, Captivate, PowerPoint‑based workflows, and LMS packaging standards.
• Experience with Learning Management Systems, curriculum management, training assignments, and learning content deployment.
• Performance consulting skills, including assessing business needs, identifying performance gaps, and recommending learning solutions.
• GxP/GMP experience in a regulated environment.
• Ability to manage multiple priorities and deadlines while maintaining safety, compliance, data integrity, and inspection readiness.
• Strong communication, collaboration, problem‑solving, continuous improvement, and attention to detail.
• Digital/AI‑first approach to all tasks.
• Exposure to continuous improvement frameworks (e.g. Lean, Six Sigma, QbD, TQM, Agile, etc.)

High School Diploma, GED, or international equivalent and at least 6 years of relevant academic and/or practical work experience. Education beyond high school will be counted as relevant experience.

Bachelor’s degree in a relevant field and at least 2 years of experience. Minimum of 2 years of technical writing, instructional design and facilitation experience.

Hybrid - West Point

• Adult Learning Theory
• Adult Learning Theory
• Articulate 360
• Biopharmaceutical Industry
• Business Consulting Services
• Competency Management
• Compliance Activities
• Compliance Monitoring
• Compliance Policies
• Compliance Program Development
• Compliance Reporting
• Compliance Training
• Continuous Improvement
• Data Integrity
• Employee Communications
• Employee Training
• GxP Compliance
• Instructional Design
• Learning Management
• Learning Management Systems (LMS)
• Medical Devices
• Metrics…