Expertise in cGMPs, 21 CFR 210/211, ICH, USP (High proficiency)Leading FDA/customer audits and inspection readiness (High proficiency)Remediation planning and effectiveness verification (High proficiency)Working with Ops, Eng, and R&D on QMS topics (High proficiency)Team coaching, mentoring, and resourcing (High proficiency)Effective internal/external stakeholder communication (High proficiency)ERP (e.g., SAP), LIMS (e.g., MasterControl), TrackWise (High proficiency)Driving transformation in quality mindset and execution (High proficiency). The ideal candidate is a hands-on, technically proficient leader with cGMP knowledge (21 CFR 210/211) and the ability to align cross-functional teams to elevate the site's quality systems and compliance.