Associate Director, Clinical Quality Lead (Fully Remote)

Osanni Bio; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.

The Senior GCP Quality Leader will oversee GCP quality across clinical development, lead deviations and CAPA, and qualify and audit CROs, sites, and vendors while partnering with Regulatory Affairs for health authority

Qualifications

• 10+ years pharma/biotech experience with 8+ years hands-on GCP.
• Proven track record building GCP quality systems and leading sponsor audits.
• Independent, collaborative leader with strong communication skills.

Responsibilities

• Lead GCP quality and manage deviations, investigations, and CAPA.
• Qualify, audit, and oversee CROs, sites, and clinical vendors.
• Partner with Regulatory Affairs and Technical Operations on health authority interactions and inspection readiness.

Skills

GCP quality oversight

Deviations & CAPA

CRO/site audits

Regulatory interactions

Communication skills

Job description

• Responsible for GCP quality oversight of clinical development activities.
• Foundational role shaping GCP quality practices across the company.

What You Will Do:

• Lead GCP quality and manage deviations, investigations, and CAPA.
• Qualify, audit, and oversee CROs, sites, and clinical vendors.
• Partner with Regulatory Affairs and Technical Operations on health authority interactions and inspection readiness.

What You Bring:

• 10+ years of pharma/biotech experience including 8+ years hands-on GCP.
• Proven track record building GCP quality systems and leading sponsor audits.
• Independent, collaborative leader with strong communication skills.

Osanni Bio

Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.