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 & 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. Direct leadership experience in quality and/or regulatory functions, particularly with advanced biological products, is essential. The role requires a strong understanding of GMP, experience with IND-stage programs, and a proven track record in developing regulatory strategies and interacting with the FDA. The ideal candidate will also have experience in clinical manufacturing, managing external partners, and be adept at building and mentoring high-performing teams. A leadership profile that includes independent judgment, clear communication, and the ability to balance multiple priorities is crucial for this position.

Functions

• Operations