Teams at KMR Search Group

Lead design, implementation, and continual improvement of a pharmaceutical quality assurance function and quality management system. Oversee SOPs, document control, batch record review, deviations, change control, CAPA, internal and vendor audits, regulatory submission support, and quality IT (e.g., Veeva). Manage quality training, vendor programs, inspections, and quality metrics to ensure regulatory compliance and product development readiness.

Lead design, implementation, and continuous improvement of a Quality Management System supporting clinical development and regulatory approval. Oversee SOPs, document control, batch record review, deviation/change control, CAPA, audits, vendor management, regulatory submission support, and inspection readiness while managing a quality team and cross-functional quality activities.

Lead global regulatory and quality assurance strategy for a clinical-stage pharmaceutical company. Oversee FDA and international submissions, manage QA systems (SOPs, CAPA, document control, training), advise senior leadership on regulatory risk, and direct cross‑functional regulatory and quality activities to ensure compliance and timely approvals.