Senior Training Manager, Quality Assurance

Duties and Responsibilities

• Lead the development and continuous improvement of the company’s GxP training and personnel qualification program, ensuring alignment with regulatory requirements and internal quality standards
• Oversee and administer training systems (LMS/eQMS), ensuring accurate training assignment, tracking, compliance, and data integrity across all functions
• Ensure inspection readiness of all training programs, including leading training-related activities during regulatory inspections and audits and defending training processes
• Establish and maintain role-based training curricula and competency frameworks, including training effectiveness strategies and performance-based qualification
• Drive cross-functional collaboration and continuous improvement, ensuring training programs are integrated with quality systems (deviations, CAPA, change control) and aligned with business and regulatory expectations

Requirements

• BS/BA in life sciences, education, or related field required
• Minimum of 3-5 years of experience in a regulated (GxP) environment, with significant experience in training, quality systems, or personnel qualification programs
• Demonstrated experience developing and managing training programs in a pharmaceutical or biotech environment
• Strong knowledge of cGMP requirements, regulatory expectations (FDA, EMA), and applicable training requirements (e.g., personnel qualification)
• Experience with Learning Management Systems (LMS) and/or electronic Quality Management Systems (eQMS)
• Strong understanding of quality systems (e.g., deviations, CAPA, change control) and their linkage to training
• Demonstrated knowledge of quality risk management principles (ICH Q9) and their application to training programs
• Proven leadership and cross-functional collaboration skills
• Strong analytical skills, including the ability to trend data and evaluate training effectiveness
• Excellent communication and presentation skills