Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.
We are seeking a Director/Senior Director, Quality Management Systems (QMS), Digital Quality Assurance and GxP Compliance to be a key leader within Crescent’s Quality organization, responsible for the design, implementation, and oversight of the Company’s Quality Management System (QMS), GxP digital quality platforms, GxP vendor management program, and inspection readiness activities.
You will provide strategic and hands-on leadership to ensure quality systems and computerized/digital systems are fit for intended use, compliant with global regulatory requirements, and scalable to support Crescent’s clinical-stage development programs. You will partner closely with cross-functional stakeholders, IT, and external vendors to ensure appropriate validation, data integrity, vendor qualification and oversight, inspection readiness, and continuous improvement within a highly outsourced operating model.