Associate Director, Quality Systems - Build Scalable QMS

Osanni Bio; San Francisco (CA); Vor Ort; USD 190.000 - 205.000; Vollzeit

Zusammenfassung

Osanni Bio, a development-stage therapeutics company in San Francisco, is hiring an Associate Director, Quality Systems to lead the hub quality management system and supplier quality programs. You will partner with IT, Technical Operations, and Clinical teams to implement practical, compliant GxP processes and systems.

The role focuses on GLP, GCP, and GMP programs, driving deviations, CAPA, change control, and document control.

Qualifikationen

• Bachelor's degree in a life science, engineering, or related field required.
• Quality certification (e.g., ASQ CQA or CMQ/OE) is a plus.
• 8+ years of pharmaceutical or biotech quality experience, including 5+ years owning or leading quality systems.
• Hands-on experience selecting, implementing, and validating electronic quality systems, with working knowledge of GAMP5, 21 CFR Part 11, Annex 11, and data integrity.
• Strong knowledge of GMP, GLP, and GCP, with supplier qualification and audits experience.
• Track record building quality systems from the ground up in a fast-paced startup or virtual company.

Aufgaben

• Own and lead Osanni's hub quality management system, defining processes that are practical and inspection-ready for GLP, GCP, and GMP programs.
• Own the supplier quality program across GLP, GCP, and GMP, including qualification, audits, and performance monitoring.
• Support selection and implementation of right-sized electronic GxP systems with IT and System Owners.
• Partner with Technical Operations on deviations, CAPA, and change control tied to CDMO and clinical supply activities.
• Extend and tailor hub systems to affiliate companies as assets progress.
• Manage multiple priorities in a fast-paced environment and ensure on-time delivery.

Kenntnisse

Collaborative communicator

GxP systems

System adoption

Ausbildung

Bachelor's degree in life sciences/engineering

Quality certification (ASQ CQA/CMQ/OE)

Tools

GAMP5

21 CFR Part 11

Annex 11

Jobbeschreibung

Osanni Bio, a development-stage therapeutics company in San Francisco, is hiring an Associate Director, Quality Systems to lead the hub quality management system and supplier quality programs. You will partner with IT, Technical Operations, and Clinical teams to implement practical, compliant GxP processes and systems.

The role focuses on GLP, GCP, and GMP programs, driving deviations, CAPA, change control, and document control.