Vice President of Quality, Sterile Drug Product Manufacturing

The Company is in search of a VP/Senior Director of Quality to lead the establishment of a modern, state-of-the-art GMP sterile manufacturing facility. The successful candidate will be responsible for building a credible, inspection-ready quality organization that can support sterile drug product manufacturing, regulatory inspections, and commercial product release. This role demands a leader with a strong background in GMP-regulated sterile drug manufacturing, particularly in aseptic processing, and experience as the FDA point of contact for inspections and investigations. The VP/Senior Director of Quality will oversee the implementation of a Quality Management System, facility qualification and validation, and ensure compliance with regulatory standards. Executive leadership skills are essential, as the role involves direct reporting to the CEO and collaboration with cross-functional teams. Applicants must have a minimum of 7 years' experience in sterile drug product GMP quality, with a Bachelor's degree in a relevant scientific discipline. An advanced degree is preferred. The role requires a hands-on approach, the ability to work with a lean team, and a commitment to delivering results without the infrastructure of a large enterprise. Experience with eQMS platforms and a background in ASQ, Lean Sigma certification, and QMS implementation are all advantageous. The ideal candidate will have a proven track record in quality systems execution, batch release, and disposition, and be adept at using quality data to drive continuous improvement. The position also involves occasional travel and the ability to work in a classified cleanroom environment.