Teams at AbSci

Provides end-to-end Sponsor operational leadership for global Phase 1–3 clinical programs. Leads feasibility, country and site strategy, enrollment modeling, start-up, CRO and vendor governance, risk management, operational readiness, compliance, and executive reporting. Applies AI, analytics, and automation to improve trial execution and oversight while partnering cross-functionally to prepare and execute a registrational Phase 3 program.

Own and continuously improve the Quality Management System across GCP, GMP, and GLP environments. Lead quality standards, SOPs, audits, vendor oversight, CAPA, deviations, change control, certifications, and inspection readiness. Partner with Regulatory, R&D, Clinical, Manufacturing, IT, and Legal to establish scalable quality foundations. The role requires broad biotech or pharma quality experience and may build a team as the company grows.

Build and lead Absci’s regulatory affairs, ethics and compliance, privacy, and government affairs functions. Develop FDA and international regulatory strategies, manage agency interactions and submissions, oversee audits and investigations, and establish GDPR-ready data governance, privacy-by-design, vendor due diligence, and breach response programs. Partner with Legal, Quality, IT, Clinical, Engineering, Product, executives, and the Board to embed compliance across the company.