Vice President, Head of Quality Assurance Greater Boston, MA Area

The Company is seeking a Vice President, Head of Quality Assurance to provide strategic and operational leadership for quality across clinical development, manufacturing, laboratories, distribution, pharmacovigilance, and external partners. The role will build and lead a scalable, phase-appropriate Quality Management System, set quality strategy and governance, and promote compliance, patient safety, and data integrity. Responsibilities include overseeing vendor qualification and audits, managing inspection readiness, and providing quality input on CMC development, clinical supply, and trial execution. The leader will also oversee product disposition, analytical documentation, deviations, investigations, CAPAs, change controls, and controlled quality documentation, while planning quality systems and resources for later-stage development. Candidates must hold a bachelor’s degree in science, engineering, or a related discipline; an advanced degree is preferred. They should have at least 15 years of progressive Quality Assurance experience in a regulated biotech or pharmaceutical environment, including leadership of a quality function, and at least five years of hands-on experience in a relevant technical discipline. Required expertise includes global GxP regulations, clinical product batch review and disposition, quality systems, audits and inspections, vendor oversight, risk management, data integrity, and computerized system validation. Candidates should demonstrate success building quality organizations and supporting clinical development, with strong communication, collaboration, problem-solving, and prioritization skills. Experience with later-stage development and oncology drug development is an advantage.

Hiring Company

Treeline Biosciences