Sr. Manager Quality

About the role

Absci is a clinical-stage biotechnology company advancing novel therapeutics using generative AI. Our Integrated Drug Creation™ platform combines cutting-edge AI models with a synthetic biology data engine, enabling the rapid design of innovative therapeutics that address challenging therapeutic targets. Absci is a global company headquartered in Vancouver, WA, and maintains offices in New York City, Switzerland, and Serbia. We are seeking a pragmatic, broad-based quality leader to own and evolve our Quality Management System and drive a culture of quality across the organization. This role is ideal for someone with solid GxP experience across multiple quality disciplines (GCP, GMP, and GLP) who operates at both a strategic and hands-on level. You don't need to be a deep specialist in one narrow area; we need someone who can see across the quality landscape, prioritize risk intelligently, and partner effectively across the organization. This is a director-level role, with the opportunity to build a team as Absci scales.

Responsibilities

• Support the buildout and implementation of a robust Quality Management System; own and continuously improve the QMS, ensuring it is fit-for-purpose and inspection-ready at all stages of development
• Define and maintain quality standards, SOPs, and process documentation across GCP, GMP, and GLP environments
• Lead and manage internal and external audits, including CRO/CMO vendor qualification and ongoing oversight
• Partner closely with Regulatory to ensure quality systems support submission requirements and agency inspections
• Oversee CAPA management, deviation handling, and change control processes
• Champion quality certifications and ensure compliance with relevant ISO standards where applicable
• Build strong relationships across R&D, Clinical, Manufacturing, IT and Legal with a creative, solutions-oriented approach.
• Partner cross-functionally to build quality foundations early in cross-functional workflows

Requirements

• 8+ years of quality experience in biotech or pharma, with hands-on exposure across at least two of GCP, GMP, or GLP
• Bachelor's degree in life sciences, chemistry, or a related field; advanced degree a plus
• Direct experience managing or supporting FDA and/or EMA inspections
• Hands-on QMS ownership — someone who has built or rebuilt a system, not just worked within one
• Risk-based mindset; able to balance rigor with the speed required in a dynamic, AI-powered environment
• Prior experience at Manager or Director level; comfort and effectiveness as a senior individual contributor

Skills

• Experience with quality oversight in cell line development, biologics manufacturing, or similar modalities
• Experience