Associate Director, Clinical Quality Lead

About the Role

The Associate Director, Clinical Quality Lead is responsible for GCP quality oversight of MiraVi’s, our first Avian, clinical development activities. Reporting to the Sr. Director of Quality and working closely with the clinical team, this role will establish and scale the procedures, systems, and risk-based quality plans that support compliant, inspection-ready clinical studies as the program evolves. It is a foundational role that will shape how GCP quality is practiced across the company.

The ideal candidate is a hands-on, independent GCP leader who can set direction and execute without heavy oversight. You bring sound, risk-based judgment, build trusted partnerships with clinical teams and external vendors, and stay steady and adaptable as priorities shift. You lead with integrity and a focus on patient safety and data integrity, and you take ownership of building systems from the ground up.

What You Will Do

• 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.

What You Bring

• Bachelor's degree in a life science, nursing, pharmacy, or related field required; advanced degree or quality certification (e.g., RQAP-GCP) a plus.
• 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; direct FDA inspection experience strongly preferred.
• Ophthalmology clinical trial experience strongly preferred.
• Independent, collaborative leader who communicates clearly, influences without authority, and right-sizes quality in a fast-paced, startup environment.

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