Sr. Manager Quality
Absci
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 9 days ago
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