Associate Director, Clinical Quality Lead - Opens in new tab

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

Associate Director, Clinical Quality Lead

Remote, USA

Who We Are

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.

Our Values:

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.

About the Role

The Associate Director, Clinical Quality Lead is responsible for GCP quality oversight of MiraVi’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.

What You Will Do

• Lead GCP quality for MiraVi 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 performing other related duties as required.

What You Bring

• Bachelor's degree in a life science, nursing, pharmacy, or related field required; advanced degree or quality certification (e.g., RQAP-GCP) a plus.
• 10+ years of pharmaceutical or biotech experience including 8+ years hands‑on GCP experience in the pharmaceutical or biotech industry, including direct experience conducting investigator site, CRO/vendor, and internal sponsor audits.
• Proven track record building GCP quality systems (SOPs, Quality Plans, quality risk management) and overseeing CROs, sites, and vendors, grounded in ICH E6(R3) and FDA regulations.
• Experience leading inspection readiness or sponsor audits; direct FDA inspection experience strongly preferred.
• Ophthalmology clinical trial experience strongly preferred.
• Independent, collaborative leader who communicates clearly, influences without authority, and right‑sizes quality in a fast‑paced, startup environment.

Below is the expected base pay range for this position plus bonus and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.

Base Pay

$190,000 - $215,000 USD

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

We will provide an intellectually stimulating, collegial and fast‑paced environment. If you are ready to be a part of building the future of transformative medicines, then we are excited to hear from you!