Healthcare quality and compliance professional with experience in academia and industry - biotechnology, pharmaceutics and medical devices. Broad background in cross-functional product development programs for orphan drugs and various therapeutic areas. Reputation for collaborating and implementing pragmatic solutions. Offering GXP compliance and quality system management expertise to medical centers, start-up, emerging or resource-limited companies.Specialties:• Strategic planning, including development and implementation of governance, due diligence for in-licensing and global outsourcing.• Develop and/or evaluate quality management systems and records for efficient and effective global product development. • Facilitate process improvement. Assess and/or develop efficient procedures and policies for sound governance. • Monitor new regulatory requirements for clinical research. Provide expert guidance relative to achieving compliance with international standards and local regulations. • Assess new product development programs for best practices and to ensure inspection readiness, including mock-inspections, training, and ongoing support for mitigation and implementation of CAPA.