Global Process Ownership & Governance
- Establish and maintain the global Training Management Process, including policies, SOPs, standards, and governance structure.
- Define process strategy, roadmap, and harmonized workflows for training, qualification, requalification, and periodic assessments.
- Ensure compliance with global regulatory expectations for GxP training documentation and data integrity.
Training Curriculum & Competency Management
- Lead development of global role-based training curricula for GxP functions (R&D, Quality, Manufacturing, Supply Chain, PV, Regulatory).
- Implement competency-based training models and qualification frameworks.
- Partner with functional leaders to ensure accurate job-role mapping and curriculum alignment.
Technology, Systems & Data Integrity
- Serve as Business Owner for the global Learning Management System (Docebo)
- Define system requirements, workflows, data standards, and integration with eQMS, LMS and Human Resource Information System.
- Oversee system validation, upgrades, periodic review, and audit readiness.
- Ensure ALCOA+ data integrity principles for training records globally.
Process Performance, Metrics & Continuous Improvement
- Develop and maintain global training KPIs: training compliance %, overdue training, curriculum accuracy, and qualification metrics.
- Lead trend analysis and escalations, presenting performance updates to Quality Council and Management Review.
- Drive process improvements, simplification, automation, and risk-based training approaches.
- Benchmark industry practices and maintain process maturity roadmap.
Inspection Readiness & Regulatory Support
- Act as global SME during health authority inspections and partner audits covering training systems and records.
- Ensure training processes remain compliant, inspection-ready, and standardized across all sites.
- Lead or support remediation of training-related findings, CAPA, and systemic enhancements.
Global Stakeholder Leadership & Change Management
- Collaborate with HR, IT, Quality, Operations, R&D, and regional/site training leads to ensure aligned execution.
- Facilitate global working groups and communities of practice for training excellence.
- Lead global communication, onboarding, and change-management activities for process and system updates.
People Development & Thought Leadership
- Provide coaching and direction to regional training managers and SMEs involved in training execution.
- Build organizational capability in learning sciences, instructional design, adult learning principles, and GxP compliance.
- Champion a culture of continuous learning and quality mindset across the enterprise.
Qualifications
QUALIFICATIONS
- Bachelor's degree in Life Sciences, Engineering, Quality, HR Learning & Development, or related field.
- 1015+ years of pharmaceutical/biotech experience with strong training, quality systems, or LMS ownership background.
- Hands-on experience with GxP training management, LMS administration, and global quality systems.
- Strong knowledge of 21 CFR 211/820, EU GMP, Annex 11, ICH Q10/Q9, and data integrity principles.
- Proven leadership in global, matrixed environments and experience supporting regulatory inspections.
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
