Note: The job is a remote job and is open to candidates in USA. Osanni Bio is hiring an Associate Director, Clinical Quality Lead to provide GCP quality oversight for MiraVi’s clinical development activities. The role will establish and scale quality procedures, systems, and risk-based plans, and support compliant, inspection-ready clinical studies.
Responsibilities
- Lead GCP quality for MiraVi as the primary Quality point of contact for clinical studies, working closely with Clinical Development and Clinical Operations from study start-up through close-out
- Build and mature the GCP quality framework by assessing gaps and establishing the procedures, systems, and training needed, including authoring and maintaining GCP SOPs
- Develop and execute study Quality Plans and quality risk management plans aligned with ICH E6(R3), and manage deviations, investigations, and CAPA
- Qualify, audit, and oversee CROs, clinical sites, and clinical vendors (e.g., reading centers, central labs, IRT, EDC, ophthalmic imaging) through quality agreements and risk-based audits
- Partner with Regulatory Affairs, Hub Quality, and Technical Operations on health authority interactions, TMF and inspection readiness, shared quality systems, and clinical supply matters such as labeling, site complaints, and temperature excursions
- Manage multiple priorities in a fast-paced, evolving environment, ensuring deliverables are completed accurately and on time, while performing other related duties as required
Skills
- Bachelor's degree in a life science, nursing, pharmacy, or related field required
- 10+ years of pharmaceutical or biotech experience including 8+ years hands-on GCP experience in the pharmaceutical or biotech industry, including direct experience conducting investigator site, CRO/vendor, and internal sponsor audits
- Proven track record building GCP quality systems (SOPs, Quality Plans, quality risk management) and overseeing CROs, sites, and vendors, grounded in ICH E6(R3) and FDA regulations
- Experience leading inspection readiness or sponsor audits
- Independent, collaborative leader who communicates clearly, influences without authority, and right-sizes quality in a fast-paced, startup environment
- Advanced degree or quality certification (e.g., RQAP-GCP) a plus
- Direct FDA inspection experience strongly preferred
- Ophthalmology clinical trial experience strongly preferred
Benefits
- Bonus
- Comprehensive benefits
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