Quality, Training Manager

Job Description

The Quality Training Manager serves as the Head of Site Training at a large‑molecule manufacturing plant, ensuring that the site training program aligns with regulatory requirements, organizational objectives, and industry best practices. This role oversees the entire site training program, supports core Quality functions, and ensures that all employees have appropriate training plans and that annual GMP training is delivered and attended.

The position interfaces with clients and regulatory authorities and partners closely with Manufacturing, Quality Assurance, Regulatory Affairs, and Supply Chain to represent the site training function and uphold a strong culture of quality, compliance, and continuous improvement.

• Lead and own the Site Training Program, ensuring it complies with current Good Manufacturing Practices (cGMP) and supports organizational goals.
• Establish, maintain, and execute the annual GMP training schedule, and lead the delivery of annual GMP training for all relevant personnel.
• Manage the Learning Management System (LMS), including configuration, user management, training assignments, and training completion tracking.
• Lead the development of LMS‑based training content using Articulate software and other e‑learning tools.
• Develop, coordinate, and deliver training materials from initial concept through program completion, ensuring content is accurate, engaging, and compliant.
• Review and approve documents within the Electronic Document Management System (EDMS) to ensure alignment with quality and documentation standards.
• Ensure new and revised documents are uploaded into the LMS and appropriately assigned for training to all impacted employees.
• Ensure all controlled documents, including SOPs, IOPs, EOPs, and STPs, are periodically reviewed, updated, and maintained in accordance with the documentation control system.
• Participate in functional and cross‑functional teams to ensure operations remain in compliance with cGMP and applicable regulatory expectations.
• Support investigations and ensure timely closure of client and regulatory audit observations related to training and compliance.
• Support regulatory filings, including prior approval submissions, renewals, updates, and supplements, by providing training‑related documentation and expertise as required.
• Manage, coach, and develop training and quality staff, where applicable, and contribute to their professional growth and performance.
• Provide clear direction, set expectations, and monitor team performance to ensure consistent delivery of high‑quality training.
• Interact with clients and project teams to support smooth execution of project‑related activities and to represent the site training function effectively.
• Plan and deliver group training sessions, workshops, and refresher courses to ensure ongoing competence and compliance across the site.
• Drive continuous improvement in training processes, documentation practices, and quality systems to enhance efficiency, reduce deviations, and improve product quality.

• Bachelor’s degree in Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline is required.
• 8 to 10 years of progressively responsible experience in Quality Assurance within biologics or pharmaceutical manufacturing environments.
• Strong understanding of current Good Manufacturing Practices (cGMP) and their application in biopharmaceutical, pharmaceutical, biotechnology, and bioprocess operations.
• Demonstrated experience managing a site‑level training program in a regulated manufacturing environment.
• Hands‑on experience with Learning Management Systems (LMS) for assigning, tracking, and documenting training.
• Experience working with an Electronic Document Management System (EDMS) for document control and approvals.
• Solid knowledge of USDA and USFDA, ICH, EU, and Health Canada regulations, as well as pharmacopeial standards relevant to biologics manufacturing.
• Experience supporting regulatory inspections and third‑party audits with successful outcomes.
• Proven ability to implement and manage robust quality training systems within a quality management framework.
• Experience in…