Associate Director, Quality Systems - Opens in new tab

Osanni Bio, Inc.; San Francisco (CA); Hybrid; USD 190,000 - 205,000; Full time

Job summary

Osanni Bio, Inc. in San Francisco is seeking an Associate Director, Quality Systems to build and lead the hub quality management system across GLP, GCP, and GMP programs.

This role defines practical processes, selects fit-for-purpose tools, and partners with affiliates as assets grow. The ideal candidate has 8+ years in pharma/biotech quality, strong experience with electronic quality systems, and a hands-on, collaborative approach to scaling quality across a fast-moving startup ecosystem.

Qualifications

• 8+ years of pharma/biotech quality experience.
• 5+ years owning or leading quality systems.
• Hands-on experience selecting, implementing, and validating electronic quality systems.
• Working knowledge of 21 CFR Part 11, Annex 11, and data integrity principles.
• Strong GMP/GLP/GCP knowledge with supplier qualification and audits.
• Startup/virtual company experience; collaborative, cross-team communicator.

Responsibilities

• Own and lead Osanni’s hub quality management system (document management, training, deviations, CAPA, change control), defining practical, inspection-ready shared processes across GLP, GCP, GMP.
• Own the supplier quality program (qualification, risk-based audits, quality agreements, performance monitoring).
• Support selection and implementation of right-sized electronic GxP systems with IT and System Owners on requirements, vendor evaluation, validation, access controls, and data integrity.
• Partner with Technical Operations on deviations, CAPA, and change control tied to CDMO and clinical supply; with Clinical on document control and training.
• Extend and tailor hub systems to affiliate companies as assets progress.

Skills

Quality leadership

GxP knowledge

Audit readiness

GMP/GLP/GCP

Data integrity

Cross-team collaboration

Education

Bachelor’s degree in life science

Quality certification (ASQ CQA/CMQ/OE)

Tools

eQMS

Job description

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, Quality Systems is responsible for establishing and leading Osanni's hub quality management system, the foundation that supports quality across our programs and, as assets progress, our Avians. Reporting to the Sr. Director of Quality, this role owns document management, training, deviations, CAPA, change control, and supplier quality across GLP, GCP, and GMP, and supports the selection and implementation of pragmatic, right-sized electronic systems. It is a foundational role that will shape how quality scales across the Osanni ecosystem.

The ideal candidate is a hands‑on builder who pairs strong QMS fundamentals with practical systems savvy. You design processes people actually use, choose tools that fit the stage of the company, and stay adaptable as needs evolve. You take ownership from requirements through go‑live and build strong partnerships across the hub and affiliate companies.

What You Will Do:

• Own and lead Osanni's hub quality management system (document management, training, deviations, CAPA, and change control), defining shared processes with Hub Quality that are practical, inspection ready, and support GLP, GCP, and GMP programs.
• Own the supplier quality program across GLP, GCP, and GMP, including supplier qualification, risk‑based audit planning, quality agreements, and ongoing performance monitoring.
• Support the selection and implementation of right‑sized electronic GxP systems, partnering with IT and System Owners on requirements, vendor evaluation, validation, access controls, and data integrity.
• Partner with Technical Operations on deviations, CAPA, and change control tied to CDMO and clinical supply activities, and with Clinical on document control and training that support GCP.
• Extend and tailor hub systems and processes to affiliate companies as assets progress.
• 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, engineering, or related field required; quality certification (e.g., ASQ CQA or CMQ/OE) a plus.
• 8+ years of pharmaceutical or biotech quality experience, including 5+ years owning or leading quality systems.
• Hands‑on experience selecting, implementing, and validating electronic quality systems, with working knowledge of computerized system validation (GAMP5, CSA principles), 21 CFR Part 11, Annex 11, and data integrity principles.
• Strong working knowledge of GMP, GLP, and GCP, with experience in supplier qualification and audits and in supporting regulatory inspections.
• Track record building quality systems from the ground up in a fast‑paced startup or virtual company environment, with a pragmatic, right‑sized approach.
• Collaborative, clear communicator who drives system adoption and builds alignment across teams and partners.

#LI-hybrid

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 - $205,000 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.