Senior Director, Quality Systems - Hybrid Startup Biotech

Osanni; San Francisco (CA); Presencial; USD 190.000 - 205.000; Jornada completa

Descripción de la vacante

Osanni Bio in San Francisco Bay Area is seeking an Associate Director, Quality Systems to establish and lead the hub quality management system across GLP, GCP, and GMP programs. You will own document control, training, deviations, CAPA, change control, and supplier quality, partnering with IT and affiliate teams.

The ideal candidate combines hands-on QMS expertise with practical systems know-how, building processes people use and scaling quality as assets progress through the Osanni ecosystem.

Formación

• 8+ years of pharmaceutical or biotech quality experience.
• 5+ years owning or leading quality systems.
• Hands-on experience selecting, implementing, and validating electronic quality systems.
• Working knowledge of 21 CFR Part 11, Annex 11, and data integrity principles.
• Knowledge of GMP, GLP, and GCP; supplier qualification and audits.

Responsabilidades

• Own and lead Osanni’s hub quality management system (document management, training, deviations, CAPA, and change control).
• Own the supplier quality program across GLP, GCP, and GMP, including supplier qualification and audits.
• Support selection and implementation of right-sized electronic GxP systems with IT.

Conocimientos

Quality systems

GxP

Data integrity

Regulatory inspections

System implementation

Educación

Bachelor’s degree in life science, engineering, or related field

Herramientas

Electronic quality systems

Descripción del empleo

Osanni Bio in San Francisco Bay Area is seeking an Associate Director, Quality Systems to establish and lead the hub quality management system across GLP, GCP, and GMP programs. You will own document control, training, deviations, CAPA, change control, and supplier quality, partnering with IT and affiliate teams.

The ideal candidate combines hands-on QMS expertise with practical systems know-how, building processes people use and scaling quality as assets progress through the Osanni ecosystem.