Quality Systems Leader for Biotech & GxP

Osanni Bio, Inc.; San Francisco (CA); Hybrid; USD 190,000 - 205,000; Full time

Job summary

Osanni Bio, Inc. in San Francisco is seeking an Associate Director, Quality Systems to build and lead the hub quality management system across GLP, GCP, and GMP programs.

This role defines practical processes, selects fit-for-purpose tools, and partners with affiliates as assets grow. The ideal candidate has 8+ years in pharma/biotech quality, strong experience with electronic quality systems, and a hands-on, collaborative approach to scaling quality across a fast-moving startup ecosystem.

Qualifications

• 8+ years of pharma/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.
• Strong GMP/GLP/GCP knowledge with supplier qualification and audits.
• Startup/virtual company experience; collaborative, cross-team communicator.

Responsibilities

• Own and lead Osanni’s hub quality management system (document management, training, deviations, CAPA, change control), defining practical, inspection-ready shared processes across GLP, GCP, GMP.
• Own the supplier quality program (qualification, risk-based audits, quality agreements, performance monitoring).
• Support selection and implementation of right-sized electronic GxP systems with IT and System Owners on requirements, vendor evaluation, validation, access controls, and data integrity.
• Partner with Technical Operations on deviations, CAPA, and change control tied to CDMO and clinical supply; with Clinical on document control and training.
• Extend and tailor hub systems to affiliate companies as assets progress.

Skills

Quality leadership

GxP knowledge

Audit readiness

GMP/GLP/GCP

Data integrity

Cross-team collaboration

Education

Bachelor’s degree in life science

Quality certification (ASQ CQA/CMQ/OE)

Tools

eQMS

Job description

Osanni Bio, Inc. in San Francisco is seeking an Associate Director, Quality Systems to build and lead the hub quality management system across GLP, GCP, and GMP programs.

This role defines practical processes, selects fit-for-purpose tools, and partners with affiliates as assets grow. The ideal candidate has 8+ years in pharma/biotech quality, strong experience with electronic quality systems, and a hands-on, collaborative approach to scaling quality across a fast-moving startup ecosystem.