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 You Will Be Successful If You: • Have 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 Preferred • 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 What We Offer Absci offers highly competitive salaries and benefits, including medical, dental, vision insurance, unlimited vacation, parental leave, employee assistance program, voluntary life and disability insurance, annual bonus potential, and 401(k) with a generous company match.