About this role
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