Senior Product Quality Lead - GMP Compliance

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 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