Remote GCP Quality Lead - Associate Director

Osanni Bio, Inc.; San Francisco (CA); Hybrid; USD 190,000 - 215,000; Full time

Benefits offered by this job

Bonus eligible

Comprehensive benefits

Job summary

Osanni Bio, Inc. is seeking an Associate Director, Clinical Quality Lead to manage GCP quality across our clinical programs.

This hands-on leader will establish risk-based quality systems, SOPs, and plans for scalable studies while partnering with the clinical team to ensure data integrity and patient safety. The role involves auditing CROs/sites, guiding CAPA processes, and coordinating with Regulatory Affairs and Operations to support inspections and health authority interactions in a dynamic,

Qualifications

• 10+ years of pharmaceutical or biotech experience including 8+ years hands-on GCP experience in the pharma/biotech industry.
• Experience leading inspection readiness or sponsor audits; direct FDA inspection experience strongly preferred.
• Experience building GCP quality systems (SOPs, Quality Plans, quality risk management) and overseeing CROs, sites, and vendors.

Responsibilities

• Lead GCP quality for MiraVi and serve as the primary Quality contact for clinical studies.
• Build and mature the GCP quality framework, authoring and maintaining SOPs.
• Develop and execute study Quality Plans and risk management plans aligned with ICH E6(R3).
• Qualify, audit, and oversee CROs, sites, and vendors through quality agreements and audits.
• Partner with Regulatory Affairs, Hub Quality, and Technical Operations on health authority interactions and inspection readiness.

Skills

GCP oversight

Audit management

Regulatory liaison

Vendor management

Quality systems

ICH E6(R3)

Education

Bachelor's degree in life science

Advanced degree or QA cert (e.g., RQAP-GCP)

Job description

Osanni Bio, Inc. is seeking an Associate Director, Clinical Quality Lead to manage GCP quality across our clinical programs.

This hands-on leader will establish risk-based quality systems, SOPs, and plans for scalable studies while partnering with the clinical team to ensure data integrity and patient safety. The role involves auditing CROs/sites, guiding CAPA processes, and coordinating with Regulatory Affairs and Operations to support inspections and health authority interactions in a dynamic,