Vice President of Quality & Regulatory Affairs

Vice President of Quality & Regulatory Affairs

About the Company

Clinical-stage biotechnology company developing innovative cell-based therapies.

Industry
Biotechnology

Type
Privately Held

About the Role

The Company is in search of a Vice President of Quality and Regulatory Affairs to spearhead the quality and regulatory functions for its clinical-stage biotechnology division. The successful candidate will be tasked with establishing and maintaining a phase-appropriate Quality Management System, providing strategic regulatory leadership, and ensuring compliance across all aspects of clinical development, manufacturing, testing, and with external partners. This executive will be a key member of the leadership team, working closely with various departments to advance programs through clinical development and toward commercialization. The role demands a hands-on approach, the ability to operate in a fast-paced environment, and a balance of strategic leadership with the capacity to make independent, risk-based decisions. Applicants must have a Bachelor's degree in a relevant field, with an advanced degree preferred, and at least 15 years' experience in biotechnology, pharmaceutical, or cell/gene therapy development, including significant leadership in quality and/or regulatory roles. Direct experience with advanced biological products, particularly in a clinical-stage setting, is essential. The role requires a strong understanding of GMP, GCP, GLP, and FDA regulatory requirements, as well as a proven track record in developing regulatory strategies and interacting with regulatory authorities. The ideal candidate will have a background in quality systems, clinical manufacturing, and vendor management, and should be adept at leading and mentoring a high-performing quality and regulatory organization.

Functions

• Operations