Sr. Director Quality Assurance

Job Title: Senior Director, Quality Assurance

Department: Quality Assurance

Location: Rochester, Minnesota or Remote

Rion is a clinical-stage biotechnology company based in Rochester, Minnesota. Rion was founded as a Mayo Clinic Employee Entrepreneurial Program startup company. Rion’s mission is to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on extracellular vesicle science. Our proprietary exosome platform has the ability to address significant unmet patient needs in many fields of medicine; accordingly, we are actively pursuing clinical programs in wound healing, cardiovascular diseases, and women’s health.

Our ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.

The Senior Director of Quality Assurance is responsible for leading the overall Quality Assurance (QA) function at Rion and providing strategic oversight of the company’s GxP Quality Management System for both human and veterinary programs. This role ensures phase-appropriate compliance across Rion’s clinical development activities, clinical trial material production, external partner oversight, and future commercialization readiness.

The Senior Director, Quality Assurance will lead Quality oversight for Rion’s product programs from toxicology through Phase 3 and commercialization. This role will ensure phase-appropriate GxP compliance across internal functions and external partners, while shaping Quality strategy, managing quality risk, and supporting regulatory readiness for Rion’s evolving development pipeline. This role will lead Quality strategy required to support Rion’s progression from phase 3 clinical development through commercialization readiness.

The Senior Director of Quality Assurance will provide QA leadership across GMP, GCP/vendor oversight, Quality Systems, Document Control, Training, product quality, audit programs, inspection readiness, and regulatory compliance activities. The role will partner cross-functionally with CMC, Regulatory Affairs, Clinical Operations, Program Management, QC, Supply Chain, and other departments to ensure Rion’s Quality systems and practices are aligned with applicable regulations, internal procedures, and business objectives.

This is a supervisory position with direct reports. The position requires approximately 15% domestic travel.

• Lead the overall Quality Assurance function and provide strategic oversight of Rion’s phase-appropriate GxP Quality Management System.
• Design, implement, maintain, and continuously improve Quality Assurance and GxP compliance programs to support clinical development, clinical trial material production, and future product registration/commercialization.
• Provide Quality Assurance input into Rion’s strategic goals, program plans, quality plans, schedules, resourcing, and budgets.
• Provide expertise and guidance to Rion departments in interpreting and implementing applicable regulatory requirements, agency guidance, industry standards, and internal procedures.

• Serve as the Quality lead for GMP activities supporting clinical trial and commercial materials, including drug substance and drug product used in early- and late-phase clinical studies and commercial products.
• Provide QA oversight for development-stage manufacturing, analytical testing, method validation/transfer, formulation, scale-up, process validation, PPQ, and commercial readiness activities.
• Review and approve GMP documentation, including batch records, specifications, labels/label proofs, protocols, reports, validation documents, and release documentation, as applicable.
• Oversee the release process for investigational and, as applicable, commercial pharmaceutical products.

• Provide GxP Quality oversight of external partners, including CDMOs, CTLs, CROs, investigator sites, and other critical service providers supporting clinical and future commercial programs.
• Lead or support vendor qualification, quality agreements, risk assessments, audits,…