Sr. Manager Quality

Absci

3d•$160,000 - $200,000

About The Position

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.

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
Legal authorization to work in the United States is required.

Nice To Haves

Experience with quality oversight in cell line development, biologics manufacturing, or similar modalities
Experience with Veeva QMS
Familiarity with AI/ML quality considerations or computer system validation (CSV/CSA)
Experience in a clinical-stage biotech building quality infrastructure from an early stage

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