Teams at Scientific Protein Laboratories

Lead design, implementation, and continuous improvement of company-level GxP and non-GxP training systems, curricula, and learning pathways. Coordinate training planning, maintain training records and systems, ensure regulatory compliance with Quality, monitor qualification status, analyze capability gaps tied to quality events, and drive training effectiveness and cross-functional alignment to support operational compliance in a regulated biopharmaceutical manufacturing environment.

Administer, configure, validate, and support the electronic Quality Management System (eQMS) and Electronic Batch Records (EBRs). Manage integrations, ensure data integrity and regulatory compliance (21 CFR Part 11, EU Annex 11, ALCOA+), develop reports/metrics, provide user support/training, execute CSV activities, and support audits and remediation in a cGMP biopharma environment.

Develops, administers, and maintains manufacturing training programs to ensure cGMP and regulatory compliance. Manages LMS and training records, coordinates onboarding and refresher training, develops SOP-based curriculum with SMEs, tracks qualifications and compliance metrics, supports audits, and drives continuous improvement of training processes.