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