The Company is seeking a Vice President, Quality Assurance to lead the establishment and maintenance of its global pharmaceutical quality system. The successful candidate will be responsible for providing independent quality oversight across the product portfolio and external GxP network, ensuring compliance with global regulations, cGxP requirements, and company standards. This role demands a leader with a strong background in quality assurance within the pharmaceutical or biotechnology industry, particularly in a fully or substantially outsourced operating model. The Vice President will be the final quality authority for batch disposition, lead regulatory inspections, and manage significant quality and compliance risks. Key responsibilities include the development and continuous improvement of the quality system, quality oversight of all manufacturing and distribution activities, and the establishment of quality agreements with external partners. Applicants for the Vice President, Quality Assurance position at the company should hold a Bachelor's degree in a relevant scientific or engineering discipline, with an advanced degree preferred, and have at least 15 years of quality experience in the industry. The role requires a candidate with a broad experience across multiple product modalities and manufacturing platforms, and a strong knowledge of global GMP and GDP requirements. The ideal candidate will have a proven track record of leading quality in a commercial setting, interacting with regulatory authorities, and making independent, risk-based decisions. Strong leadership, communication, and problem-solving skills are essential, as is the ability to manage a high-performing quality organization and foster a culture of quality and continuous improvement.

Hiring Company

Celgard