Own the site training procedure(s) and the training and qualification process, ensuring compliance with 21 CFR Parts 210/211 (pharmaceutical cGMP), 21 CFR Part 820 (QMSR), 21 CFR Part 4 (combination products), ISO 13485:2016, applicable ICH guidelines (Q7, Q9, Q10), EU GMP / PIC/S where applicable, BD corporate requirements, and other applicable regulatory agency expectations. The Training Manager ensures training records are complete, accurate, and inspection-ready, that training is consistent across all shifts, and that training-related root causes identified through nonconformances, CAPAs, complaints, and audits are corrected effectively and sustainably.