Manager, Product Quality Lead

Osanni Bio; San Francisco (CA); Hybrid; USD 145,000 - 160,000; Full time

Job summary

Osanni Bio is a development-stage therapeutics company seeking a Product Quality Lead to oversee GMP quality across clinical programs, manage batch documentation, deviations, CAPAs and regulatory support. The role reports to the Sr.

Director of Quality and partners with Technical Operations and external partners to maintain compliance. The ideal candidate has hands-on cGMP experience, strong risk-based judgment, and a patient-centered approach to ensure product quality and safety as programs

Qualifications

• Bachelor-level degree and GMP experience essential.
• Experience leading deviations, investigations, OOS/OOT events and CAPAs.
• Familiarity with cGMP, ICH, FDA/EMA expectations for investigational products.

Responsibilities

• Represent Quality in program team, CMC, and Technical Operations forums.
• Own GMP batch documentation review and disposition for drug substance/product and clinical supplies.
• Lead quality event documentation, deviations, investigations, CAPAs, and change controls.

Skills

GMP quality oversight

Batch record review

Deviation investigations

CAPA and change control

Regulatory submissions support

Analytical data review

Cross-functional collaboration

Education

Bachelor's degree in chemistry, biology, pharmaceutical sciences, engineering, or related

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.

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

About the Role:

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.

What You Will Do:

• 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 events, CAPAs, and change controls, and advising process owners on root cause analysis, product impact, and downstream validation or filing considerations.
• Provide quality oversight of CDMOs and contract testing laboratories, including audit support, batch‑related escalations, quality agreements, and metrics review, and partner with Analytical Development on specifications, method validation and transfer, reference standard qualification, and stability programs.
• Support regulatory filings and health authority information requests, and strengthen the fit-for-phase quality framework through SOPs, quality risk management, validation strategies, and product quality metrics that surface emerging risks to the Sr. Director of Quality.
• Manage multiple priorities in a fast‑paced, evolving environment, ensuring deliverables are completed accurately and on time, while performing other related duties as required.
• Minimal travel to CDMOs as needed (estimated once per quarter).

What You Bring:

• Bachelor's degree in chemistry, biology, pharmaceutical sciences, engineering, or a related scientific discipline.
• 6+ years of pharmaceutical or biotech experience in a GMP environment, in quality, technical operations, manufacturing, or analytical roles, with substantial exposure to product quality decision‑making.
• Experience with GMP batch record review and clinical product disposition, and hands‑on experience leading deviations, investigations, OOS or OOT events, CAPAs, and change control assessments, with a track record of clear, defensible documentation.
• Strong working knowledge of cGMP, ICH (including Q7, Q8 through Q10, and Q3A/Q3B), FDA and EMA expectations for investigational products, and 21 CFR Part 11 data integrity requirements, along with sufficient command of analytical methods, specifications, and stability programs to critically review data packages.
• Experience providing quality oversight of CDMOs and contract testing laboratories and supporting regulatory submissions such as INDs, IMPDs, NDAs, BLAs or MAAs; experience with sterile injectable or parenteral drug products strongly preferred, and familiarity with peptides, oligonucleotides, or other synthetic modalities is a plus.
• Highly self‑directed, with sound risk‑based judgment and excellent written and verbal communication skills, able to articulate quality positions clearly and persuasively to scientific, technical, and executive audiences; experience in a development‑stage or growing biotech or pharmaceutical company preferred.

The expected base pay range for this position is $145,000 - $160,000 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.

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.