Sr. Manager Quality

Absci Corp.; Northern (KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Absci Corp, a clinical-stage biotechnology company leveraging generative AI, seeks a pragmatic quality leader to own and evolve the Quality Management System across GxP disciplines. You will partner with Regulatory, R&D, Manufacturing, IT and Legal to ensure inspections readiness, risk-based quality decisions, and ISO alignment while guiding audits and CAPA across CRO/CMO relationships.

This role combines strategic oversight with hands-on implementation to build quality infrastructure in an

Qualifications

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

Responsibilities

• Build out and implement 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.

Skills

Quality leadership

GxP experience

Audits management

CAPA management

Regulatory liaison

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree a plus

Tools

Veeva QMS

Job description

About Absci

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. Learn more at www.absci.com or follow us on LinkedIn @absci, X @Abscibio, and YouTube.

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.

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 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.

Legal authorization to work in the United States is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, sexual orientation, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, marital status, or any characteristic protected under applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which they have applied should make a request to the recruiter or hiring manager, or contact [e-mail].