Manager, cGMP Training & Learning Programs

Leader Responsibilities • Leads and develops a high-performing Training department

• Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy

• Establish clear departmental goals aligned with organizational quality and operational objectives

• Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications

• Fosters a culture of quality ownership, compliance, and continuous improvement

• Oversees daily workflow of the department

Duties & Responsibilities • Own and maintain the corporate GxP Training Program.

• Develop and maintain training policies, procedures, and governance practices.

• Ensure training processes comply with applicable GxP regulations and industry requirements.

• Establish systems supporting employee onboarding, qualification, retraining, and continuing education.

• Monitor organizational training health and compliance.

• Manage training coordinators and training administrators as applicable.

• Provide guidance and support to departmental trainers and subject matter experts.

• Develop training governance and site-wide training standards.

• Support qualification of trainers and training owners.

• Establish departmental objectives and performance metrics.

• Lead continuous improvement initiatives within the training function.

Learning Management System Administration

• Maintain and optimize electronic Learning Management System (LMS) processes.

• Ensure training assignments are current, accurate, and aligned to job responsibilities.

• Oversee user access, curricula management, and training workflows.

• Partner with Information Technology and system administrators on validation, upgrades, and enhancements.

• Ensure data integrity and inspection readiness of training records.

Role-Based Curriculum Development

• Develop and maintain role-based training curricula for all cGMP functions.

• Ensure curricula accurately reflect required competencies and job functions.

• Collaborate with department leaders to define qualification requirements.

• Periodically assess training requirements to ensure continued effectiveness and compliance.

• Support creation of learning paths for new and existing employees.

Employee Qualification Program

• Develop and maintain personnel qualification programs.

• Ensure qualification requirements are documented and consistently applied.

• Establish qualification standards for critical GMP activities.

• Coordinate qualification and requalification activities.

• Monitor ongoing competency requirements.

Training Effectiveness Program

• Establish mechanisms to evaluate training effectiveness.

• Develop tools to assess employee comprehension and competency.

• Monitor trends related to human error and training-related deviations.

• Collaborate with management to identify performance gaps and targeted learning opportunities.

• Drive continual improvements to training methodologies.

New Employee Onboarding

• Manage GMP onboarding programs for new employees.

• Ensure timely completion of required training prior to independent work.

• Coordinate cross-functional participation in onboarding activities.

• Standardize onboarding processes across departments.

Inspection Readiness Support

• Maintain training records in a state of continuous inspection readiness.

• Support client audits, internal audits, and regulatory inspections.

• Coordinate retrieval and presentation of training records during inspections.

• Ensure training-related observations are addressed through effective remediation plans.

Metrics and Compliance Monitoring

• Partner closely with Quality Systems personnel to ensure appropriate training support for the QMS and ensure training impacts are appropriately assessed and implemented when quality systems change.

• Develop and maintain training performance metrics and dashboards.

• Provide routine reporting to leadership and Management Review.

Quality Culture & Continuous Improvement

• Promote a culture of ownership, accountability, and compliance.

• Develop educational programs that strengthen quality culture across the organization.

• Identify opportunities to improve learning effectiveness and employee engagement.

• Support implementation of modern adult-learning principles and workforce development strategies.

Required Skills & Abilities • Thorough understanding of FDA, EU, ICH, and cGMP training requirements.

• Strong knowledge of Quality Management Systems.

• Experience designing qualification and competency programs.

• Demonstrated ability to collaborate and work in cross-functional teams.

• Strong presentation and facilitation skills.

• Exceptional organizational and project management skills.

• Ability to influence personnel across all organizational levels.

• Strong analytical and problem-solving capabilities.

• Excellent written and verbal communication skills.

• Proficiency with LMS platforms, Microsoft Office, and electronic quality systems.

Education & Experience • Bachelor's degree in Life Sciences, Education, Organizational Development, Quality, Engineering, or related discipline required.

• Minimum of 5-8 years of experience in pharmaceutical, biotechnology, medical device, or CDMO environments.

• Minimum of 3 years managing GxP training programs or quality systems.

• Experience supporting client audits and regulatory inspections.

• Experience administering electronic learning management systems.

• Demonstrated understanding of cGMP regulations and personnel qualification requirements.

Physical Requirements • Prolonged periods of sitting or standing at a desk and working on a computer.

• Must be able to lift up to 15 pounds at a time

• Adheres to consistent and predictable in-person attendance