Teams at Miltenyi Biotec

Leads global quality assurance, audit, supplier quality, inspection readiness, and compliance programs for biologics manufacturing and outsourced GxP operations. Oversees audits, supplier qualification, quality agreements, risk management, corrective actions, regulatory inspections, SOPs, and approved supplier list maintenance. Manages and develops audit and supplier quality teams while driving cross-functional improvement initiatives and supporting regulatory submissions.

Leads regulatory CMC strategy and execution for cell and gene therapy programs across global regions. Oversees CMC content for INDs, CTAs, BLAs, and MAAs; supports health authority interactions, process changes, comparability, validation, change control, risk mitigation, and post-approval lifecycle management. Partners with development, manufacturing, regulatory operations, and external consultants to deliver submission-ready documentation and support clinical development, marketing authorization, and commercial launch activities.

Leads global CMC Regulatory Affairs strategy for a Cell and Gene Therapy portfolio across development, registration, commercialization, and lifecycle management. Oversees regulatory submissions, manufacturing change assessments, process and analytical strategies, health authority interactions, risk mitigation, and compliance with global requirements. Manages and mentors CMC Regulatory Affairs leaders while collaborating with process development, manufacturing, quality, supply chain, and clinical development teams.