Manager, Product Quality Lead

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

Job summary

Osanni Bio in San Francisco Bay Area seeks a Product Quality Lead (PQL) to oversee product quality across clinical manufacturing, testing, packaging, and distribution. You will review GMP batch records, manage quality events, and coordinate with CDMOs and external partners to ensure compliance with cGMP and ICH requirements.

The ideal candidate has hands-on cGMP experience, strong risk-based judgment, and a patient-centered approach to quality.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 6+ years of pharmaceutical/biotech GMP experience in quality, operations, manufacturing, or analytical roles.
• Experience with GMP batch record review and handling deviations, investigations, CAPAs, and change control.
• Strong knowledge of cGMP, ICH (Q7–Q10, Q3A/Q3B), FDA/EMA expectations, and 21 CFR Part 11.
• Experience overseeing CDMOs and contract labs; regulatory submission support including INDs/NDAs/BLAs/MAAs; sterile products preferred.
• Strong written and verbal communication; capable of presenting to scientific, technical, and exec audiences.

Responsibilities

• Serve as the primary QA partner for assigned programs, representing Quality in teams and mentoring partners on GMP expectations.
• Own GMP batch documentation review and disposition for drug substances and products.
• Lead quality events documentation, deviations, investigations, CAPAs, and change controls with root-cause analysis guidance.
• Oversee CDMOs and contract testing labs; audit support; ensure data integrity and quality agreements.
• Support regulatory filings and information requests; develop SOPs and risk management frameworks.
• Manage multiple priorities in a fast-paced environment and coordinate with QA, Clinical, and Ops teams.
• Travel to CDMOs as needed (approximately quarterly).

Skills

GMP experience

Quality decision-making

Documentation/writing

CDMOs oversight

Regulatory submissions support

Analytical data review

Effective communication

Education

Bachelor's degree in chemistry/biology/pharmaceutical sciences/engineering

Job description

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.

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 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.

This role is based in the San Francisco Bay Area and requires working on‑site 3 days/week.

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.

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

$145,000 - $160,000 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!