Quality management executive with over 30 years of diverse experience in global pharmaceutical, biopharmaceutical, medical device, and 503B industries. Public, private, global, venture capital, and private equity company experience. Expertise in regulatory compliance including current FDA, ex-US, and ISO requirements. Highly proficient in regulatory inspection preparation. Entrepreneurial mindset in building teams, designing business processes, and strategic planning. Success in gaining Board level endorsement for compliance improvement programs. Strong collaborator who thrives at continually improving business processes and managing multiple priorities in matrixed organizations. An excellent communicator who focuses on satisfying diverse customers and partner’s needs.Specialties: Pharmaceutical and biopharmaceutical manufacturing, strategic business planning, aseptic processing, technology transfer, quality management system design and implementation, new product introductions, complex root cause analyses and investigations, continuous improvement methodologies, quality operations, GMP inspection management, global leadership in matrix organizations, organizational change management and integration, company Board engagement (risk management, risk mitigation, compliance committee review, and continuous improvement efforts).
Listed skills include Gmp, Fda, Pharmaceutical Industry, Validation, and 33 others.