Vice President of Quality

Damora Therapeutics is an innovative biotechnology company that aims to fundamentally redefine care for people with hematologic disorders. We are advancing a new generation of biologics to treat mutant calreticulin-driven myeloproliferative neoplasms, including essential thrombocythemia and myelofibrosis, where there is significant medical need for new disease-modifying treatments. With multiple programs with best-in-class potential on track to enter clinical development in 2026, our goal is to rapidly bring forward optimized treatments with broad mutation coverage and exceptional convenience to dramatically improve patient outcomes. This is a unique opportunity to join a high-growth company at a formulative stage, where you will help create a foundation for corporate communications that directly impact the company’s narrative, reputation and value. About the Role As we build out the company’s core functions, we’re hiring the VP of Quality to establish the quality organization from the ground up and serve as the company’s senior quality leader. Reporting to the Chief Operating Officer, this role spans GMP (manufacturing and CMC quality), GCP (clinical quality and data integrity), GLP (Good Laboratory Practices) and Quality Systems. The ideal candidate brings a strong GMP background and the breadth to lead quality across all GxP disciplines. This is a builder’s role. You’ll design and implement phase-appropriate quality systems, processes, and culture that keep us compliant, inspection-ready, and moving fast — right-sized to our stage of development rather than carrying a commercial-scale apparatus. Because our manufacturing and clinical activities run through external partners, you’ll be especially focused on building rigorous oversight of CMOs and CROs. You’ll be both strategic and hands‑on, partnering closely with Manufacturing, Clinical, Regulatory, and IT, and advising the executive team on quality strategy, risk, and resourcing. The role requires periodic travel to CMO, CRO, and vendor sites for audits and oversight activities. Key Responsibilities Build the Quality Management System (QMS). Design and implement a single, phase-appropriate QMS spanning GMP, GCP, and GLP, including document control, deviations/CAPA, change control, training, quality risk management, audit management, and quality governance, that scales with the pipeline. Own GMP compliance and product quality (near-term priority). Serve as the senior quality authority for GMP across drug substance, drug product, and fill‑finish; oversee batch record review, deviation management, and disposition/release of clinical supply; and partner with Manufacturing and Regulatory on specifications, stability, and CMC documentation for Damora’s antibody pipeline. Lead CMO and manufacturing vendor oversight. Establish and manage quality oversight of contract manufacturers, testing labs, and other GMP vendors — qualification, quality agreements, person-in‑plant support, audits, and ongoing performance management. Establish and lead GCP and clinical quality. Build and scale clinical quality oversight as trials advance in collaboration with clinical operations and clinical compliance — clinical trial conduct, data integrity, risk assessment and management and trial master file (TMF) oversight — ensuring patient safety and data reliability across the clinical program. Oversee CRO, clinical vendor, and site quality. Lead qualification, auditing, and ongoing quality oversight of CROs, clinical laboratories, and investigator sites, including quality agreement creation and management and issue management. Partner cross-functionally. Work shoulder-to-shoulder with Manufacturing, Clinical, Regulatory, and IT to embed quality into how each function operates, balancing compliance with speed and pragmatism. Drive inspection and audit readiness across GMP and GCP. Prepare the organization and its partners for regulatory inspections and sponsor/partner audits; serve as the company’s primary quality interface with health authorities; lead internal audits and host external ones. Build and lead the Quality organization. As the organization scales, hire, develop, and manage a growing team, fostering a culture where quality is a shared responsibility rather than a gatekeeping function. Advise leadership. Serve as a trusted advisor to the COO and executive team on quality strategy, risk, governance, and investment decisions. Qualifications At least 15 years of progressive quality experience in the pharmaceutical or biotech industry, with 5+ years in a leadership position. Prior experience at a biotech company, ideally clinical-stage, with a strong grasp of what stage-appropriate quality looks like in a resource-conscious environment. Deep, demonstrated expertise in GMP, including experience overseeing external/CMO manufacturing. Working fluency in GCP and clinical quality oversight to support the growing clinical program. Direct experience preparing for and hosting FDA and/or EMA inspections. Experience standing up electronic quality and document management systems (eQMS/EDMS). Hands-on experience with antibody manufacturing quality; experience with complex multispecific modalities preferred. Demonstrated people-management experience, including building and leading teams. Track record of establishing or substantially scaling quality systems, not just operating within mature ones. Strong working knowledge of FDA, EMA, and ICH regulations and guidance. Excellent cross-functional collaboration and influencing skills; comfortable operating with ambiguity and limited infrastructure. Bachelor’s degree in a life sciences or related field required; advanced degree preferred. At Damora Therapeutics, we offer competitive compensation and thoughtfully designed total rewards aligned with industry benchmarks. We believe in rewarding impact and building meaningful ownership for our team. #J-18808-Ljbffr Damora Therapeutics