Associate Director, Clinical Quality Lead

Osanni Bio is a development-stage therapeutics platform, headquartered in San Francisco, California. We are creative and agile innovators, relentlessly curious about finding new ways to target the biology behind diseases with the greatest unmet need and determined to do something about it.

At the center of Osanni is its innovation engine, which is optimized for discovering new scientific insights, designing novel drug concepts, and efficiently advancing programs to a meaningful proof-of-concept. Once a program is sufficiently de-risked, it graduates into its ecosystem of affiliate companies, which are equipped with the dedicated focus, specialized talent and support necessary to scale. Osanni’s architecture marries the scientific depth and operational power of a centralized platform with the speed, agility and accountability of independent companies.

The result: an opportunity to create and deliver more transformative medicines.

We hold patients and the physicians who care for them as our North Star. It guides our purpose, sharpens our decision-making, and defines our impact. Osanni is currently advancing programs in ophthalmology, cardiology and beyond. We are building a highly skilled team, passionate about having an impact on human health. Be part of creating an organization where people enjoy their work and their colleagues, are valued for their individuality, and can’t imagine working anywhere else.

Osanni is guided by three core values:
Integrity + Impact, because we give a hoot;
Agility + Accountability, so we swoop and soar; and Collaboration + Connection, to be one Osanni Flock. Together, they shape how our team shows up for patients, for each other, and for the mission.

The Associate Director, Clinical Quality Lead is responsible for GCP quality oversight of Mira Vi’s, our first Avian, clinical development activities. Reporting to the Sr. Director of Quality and working closely with the clinical team, this role will establish and scale the procedures, systems, and risk-based quality plans that support compliant, inspection-ready clinical studies as the program evolves. It is a foundational role that will shape how GCP quality is practiced across the company.

The ideal candidate is a hands‑on, independent GCP leader who can set direction and execute without heavy oversight. You bring sound, risk‑based judgment, build trusted partnerships with clinical teams and external vendors, and stay steady and adaptable as priorities shift. You lead with integrity and a focus on patient safety and data integrity, and you take ownership of building systems from the ground up.

• Lead GCP quality for Mira Vi as the primary Quality point of contact for clinical studies, working closely with Clinical Development and Clinical Operations from study start‑up through close‑out.
• Build and mature the GCP quality framework by assessing gaps and establishing the procedures, systems, and training needed, including authoring and maintaining GCP SOPs.
• Develop and execute study Quality Plans and quality risk management plans aligned with ICH E6(R3), and manage deviations, investigations, and CAPA.
• Qualify, audit, and oversee CROs, clinical sites, and clinical vendors (e.g., reading centers, central labs, IRT, EDC, ophthalmic imaging) through quality agreements and risk‑based audits.
• Partner with Regulatory Affairs, Hub Quality, and Technical Operations on health authority interactions, TMF and inspection readiness, shared quality systems, and clinical supply matters such as labeling, site complaints, and temperature excursions.
• Manage multiple priorities in a fast‑paced, evolving environment, ensuring deliverables are completed accurately and on time, while…