Quality, Training Manager

Quality, Training Manager

Job Title:

Quality Training ManagerJob DescriptionThe Quality Training Manager serves as the Head of Site Training at a large-molecule manufacturing plant and ensures 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, that annual GMP training is delivered and attended, and that all training is completed in a timely manner. 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.

Responsibilities

• 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, w 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.

Essential Skills

• 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 quality management, quality assurance, and compliance within a cGMP-regulated environment
• Demonstrated ability to lead or support process improvement and continuous improvement initiatives
• Strong skills in training development, including design, delivery, and evaluation of training programs
• Ability to perform effective group training sessions and communicate complex concepts clearly
• Demonstrated leadership skills, including the ability to work in cross-functional teams and build strong relationships across departments
• Ability to manage, coach, and develop quality personnel and provide direction to drive team performance and excellence.

Additional Skills & Qualifications

• Master's degree in a relevant scientific discipline is a plus
• Experience as an auditor, either internal or external, is an advantage
• Experience using Articulate or similar e-learning authoring tools to develop LMS-based training content
• Background in biopharmaceutical, pharmaceutical, biotechnology, or bioprocess environments
• Familiarity with quality management systems, document control, and document management best practices
• Proven ability to drive continuous improvement projects that enhance efficiency, reduce deviations, and increase product quality
• Strong interpersonal skills to interact with clients, project teams, and cross-functional stakeholders
• Ability to foster a culture of quality, compliance, accountability, and safety
• Comfort working in environments subject to frequent regulatory inspections and client audits.

Work EnvironmentThe role is based within a large-molecule manufacturing plant and involves regular presence on both the manufacturing floor and in laboratory settings. The environment is highly regulated and cGMP-compliant, with a strong emphasis on safety, documentation, and adnce to standard operating procedures. The position requires frequent interaction with Manufacturing, Quality Assurance, Regulatory Affairs, Supply Chain, and client teams, as well as engagement with regulatory authorities during inspections and audits. The culture emphasizes innovation, scientific rigor, and collaboration, with a focus on helping clients solve complex scientific problems, improve R D productivity, accelerate time to market, and reduce innovation costs. Safety is central to operations, with shared responsibility and accountability for following safety guidelines, procedures, and SOPs. Standard professional and site-appropriate attire, including any required personal protective equipment, is expected when working on the manufacturing floor and in laboratory areas.

Job Type & LocationThis is a Contract position based out of Baltimore, MD.Pay and BenefitsThe pay range for this position is $50.00

• $62.

00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Pr.

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