Manager, Product 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.

This position is based in our SF headquarters on-site 2-3 days/week.

The Product Quality Lead (PQL) is responsible for product quality oversight of assigned programs, serving as the primary Quality Assurance point of contact for drug substance and drug product across clinical manufacturing, testing, packaging, and distribution. This role owns GMP batch documentation review and disposition, serves as the Quality lead for quality event documentation, and provides oversight of specifications, stability, and external manufacturing and testing partners, ensuring material is manufactured, tested, and released in compliance with cGMP, ICH, and applicable global regulatory requirements.

Reporting to the Sr. Director of Quality, the role scales fit-for-phase quality systems and practices as programs advance through development.

The ideal candidate brings deep hands‑on cGMP product quality experience, sound risk‑based judgment, and a patient‑centered view of every quality decision, recognizing that product quality directly affects the safety of the patients and study participants who receive it. This individual is comfortable working both strategically and hands‑on, and partners easily with Technical Operations, Clinical, and external partners. Quality standards are held firmly while programs keep moving, reflecting the accountability and collaboration Osanni expects across the Flock.

• Serve as the primary Quality Assurance business partner for assigned programs, representing Quality in program team, CMC, and Technical Operations forums and mentoring cross‑functional and external partners on GMP expectations and quality decision‑making.
• Own GMP batch documentation review and disposition for drug substance, drug product, and packaged clinical supplies, including executed batch records, analytical data packages, and certificates of analysis.
• Serve as the Quality lead for quality event documentation and change control, reviewing and approving deviations, investigations, OOS and OOT…