Senior Specialist, Quality Training (Contract)

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients.

About the role

The Sr. Specialist, Quality Training (Contract), will support 4DMT's Quality Training Program, ensuring governance, regulatory compliance, learning management system administration, and training performance outcomes across the organization. This role will assist the Quality Training Lead with GxP learning strategies and regulatory training compliance, support training requirements and processes, and aid in inspection readiness and record maintenance.

Responsibilities

• Support the training governance framework, policies, and standards for the GxP training program
• Assist with Learning Management System (LMS) administration and related processes with IT LMS system administrators
• Serve as the LMS business administrator to create, edit, and retire training items, curricula, and training assignments in GxP functional areas
• Coordinate and aid with regularly scheduled GxP / Quality onboarding training for new hires
• Manage, track, and prioritize training requests from the business for curricula and course management, training assignments, and reporting
• Partner and support functional leaders across the business with enterprise-wide, role-based training requirements and implement within the LMS
• Gather and provide training data to integrate training metrics for department communications or Quality Management Review process
• Support the records management of training and qualification records (physical and electronic)
• Support audits/inspections of the training program and provide assistance during regulatory inspections

Requirements

• 3-5 years of progressive experience in the biotech/pharmaceutical industry
• 2+ years supporting GxP training programs, LMS management, or Quality Systems
• General knowledge of adult learning principles, instructional design, and project management
• General understanding of global GxP regulations (FDA, EMA, ICH, etc.)
• Knowledge in learning management systems and quality systems
• Business knowledge of Clinical Research, Development, and Manufacturing in the pharmaceutical industry
• Experience working within one or more GxP disciplines: GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GDP (Good Distribution Practice)

Qualifications

• B.S. or B.A. preferred
• Knowledge of LMS administration and processing
• Excellent written and verbal communication skills
• Strong organizational skills
• Proficiency in Microsoft Office (Outlook, OneNote, Excel, Word, PowerPoint), Adobe Acrobat, survey tools
• Knowledge of good documentation principles

Physical Requirements and Working Conditions

• Physical Requirements: Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
• Working Conditions: The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Pay

Hourly compensation range: $55.00 - $64.00