Vice President of Quality & Regulatory Affairs

The Company is seeking a VP of Quality and Regulatory Affairs to provide executive leadership in defining and executing the strategic direction for quality and regulatory functions. The successful candidate will be responsible for the oversight of quality assurance, quality control, compliance, validation, supplier quality, and quality systems across all product development, clinical manufacturing, and commercial activities. This role requires a strategic leader with extensive knowledge of global GMP regulations, FDA, EMA, ICH, and international quality standards, and a proven track record in maintaining and improving Quality Management Systems in biotechnology or pharmaceutical environments. The VP will also be the main liaison with global health authorities, ensuring that all products meet the highest standards of safety, efficacy, and compliance. Candidates for the VP position should have a Bachelor's degree in a scientific discipline, with an advanced degree preferred, and at least 15 years of senior regulatory and QA/QC experience in the pharma biotechnology/pharmaceutical industry. The role demands a leader with strong expertise in quality assurance, quality control, validation, supplier quality, and risk management, as well as experience in leading regulatory inspections and managing compliance. The ideal candidate will have a background in drug/device combination products, be a strategic thinker, and possess excellent leadership, collaboration, and communication skills. A hands-on, entrepreneurial approach, and the ability to foster a culture of quality, integrity, and continuous improvement are essential.