Manager, cGMP Training & Learning Programs

Your tasks

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.

Requirements

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.

Other

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