Senior GCP Quality Lead for Ophthalmic Trials

Osanni Bio; United States; On-site; USD 190,000 - 215,000; Full time

Job summary

Osanni Bio in San Francisco is seeking an Associate Director, Clinical Quality Lead to provide GCP quality oversight for MiraVi's clinical development activities. Reporting to the Sr.

Director of Quality, you will establish risk-based quality plans and scalable procedures that keep studies inspection-ready as programs evolve. The ideal candidate is hands-on, independent, and able to partner with clinical teams and external vendors to ensure patient safety, data integrity, and compliance with ICH

Qualifications

• Bachelor's degree in a life science, nursing, pharmacy, or related field.
• 10+ years of pharmaceutical or biotech experience with 8+ years hands-on GCP experience.
• Proven track record building GCP quality systems and overseeing CROs, sites, and vendors.
• Ophthalmology clinical trial experience strongly preferred.

Responsibilities

• Lead GCP quality for MiraVi as the primary Quality point of contact for clinical studies.
• Build and mature the GCP quality framework by assessing gaps and establishing procedures, systems, and training (GCP SOPs).
• Develop and execute study Quality Plans and risk management plans aligned with ICH E6(R3).
• Qualify, audit, and oversee CROs, clinical sites, and vendors through quality agreements and risk-based audits.
• Partner with Regulatory Affairs, Hub Quality, and Technical Operations on health authority interactions and inspection readiness.
• Manage multiple priorities in a fast-paced environment, ensuring timely, accurate deliverables.

Skills

GCP quality

Quality systems

FDA regulations

Audit leadership

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Advanced degree/quality certification

Job description

Osanni Bio in San Francisco is seeking an Associate Director, Clinical Quality Lead to provide GCP quality oversight for MiraVi's clinical development activities. Reporting to the Sr.

Director of Quality, you will establish risk-based quality plans and scalable procedures that keep studies inspection-ready as programs evolve. The ideal candidate is hands-on, independent, and able to partner with clinical teams and external vendors to ensure patient safety, data integrity, and compliance with ICH