Vice President of Quality

About the role

Damora Therapeutics is seeking a Vice President of Quality to build and lead its quality organization from the ground up. Reporting to the COO, you will oversee GMP, GCP, and GLP functions, ensuring compliance while supporting rapid development of novel biologics for hematologic disorders.

Key responsibilities

• Design and implement a phase‑appropriate Quality Management System (QMS) covering GMP, GCP, and GLP.
• Serve as the senior authority for GMP compliance, overseeing batch record review, deviation management, and release of clinical supplies.
• Lead quality oversight of contract manufacturers, testing labs, CROs, and other external partners.
• Partner with Manufacturing, Clinical, Regulatory, and IT teams to define specifications, stability programs, and CMC documentation.
• Drive quality risk management, change control, audit management, and CAPA processes.
• Provide strategic advice to the executive team on quality strategy, resource planning, and risk mitigation.

Required profile

• Extensive experience in GMP environments, preferably within biotech or pharmaceutical development.
• Broad knowledge of GCP, GLP, and overall GxP quality systems.
• Proven ability to build quality functions in high‑growth, early‑stage companies.
• Strong collaborative mindset with experience working with CMOs, CROs, and cross‑functional teams.
• Willingness to travel periodically for audits and vendor oversight.

Required skills

• GMP compliance
• GCP and GLP knowledge
• Quality Management System (QMS) implementation
• CAPA (Corrective and Preventive Action) management
• Change control processes
• Audit management
• Quality risk management