Sr. Manager Quality
Absci · Remote
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Role summary
Absci seeks a senior quality leader to establish and evolve their quality management system across GCP, GMP, and GLP environments. The role combines strategic oversight with hands-on involvement, requiring broad GxP experience and the ability to scale quality infrastructure as the clinical-stage biotech grows.
What they're looking for
- 8+ years quality experience in biotech or pharma with hands-on GCP, GMP, or GLP exposure
- Bachelor's degree in life sciences, chemistry, or related field
- Direct experience managing or supporting FDA and/or EMA inspections
- Demonstrated QMS ownership through building or rebuilding quality systems
- Risk-based decision-making approach balancing rigor with operational speed
- Manager or Director-level experience with senior individual contributor capabilities
What you'll be doing
- Build and implement robust quality management system ensuring fit-for-purpose design and inspection readiness
- Define quality standards, SOPs, and documentation across GCP, GMP, and GLP environments
- Lead internal and external audits, including CRO/CMO vendor qualification and oversight
- Oversee CAPA management, deviation handling, and change control processes
- Partner with regulatory, R&D, clinical, manufacturing, and IT teams to embed quality early
Privacy & handoff
This role links to Absci's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.