Sr. Director Quality Assurance

Overview

Sr. Director Quality Assurance Jobs in Rochester, MN at Rion

Title: Sr. Director Quality Assurance

Company: Rion

Location: Rochester, MN

Job Title:  Senior Director, Quality Assurance

Department:  Quality Assurance

Location: Rochester, Minnesota or Remote

Rion’s Mission:

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.

Position Summary

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.

Responsibilities

Quality Strategy and QMS Leadership

• 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.

GMP / CMC Quality Oversight

• 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.

Vendor and External Partner Quality

• 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, QA‑to‑QA relationships, and routine quality checkpoints for critical GxP vendors.
• Oversee tracking, follow-up, and resolution of critical and major findings from internal audits, external audits, vendor audits, and regulatory inspections.

Quality Systems, Investigations, CAPA, and Risk Management

• Provide oversight of deviations, product complaints, investigations, root cause analysis, CAPAs, change controls, and quality risk management activities.
• Ensure investigations are scientifically sound, risk-based, appropriately documented, and completed in accordance with applicable procedures and regulatory expectations.
• Manage the overall CAPA program, including CAPAs resulting from deviations, audits, inspections, complaints, and other quality events.

Document Control, Training, and Quality Records

• Create, revise, review, approve, and maintain QMS-related documents, including policies, SOPs, forms, guidelines, and QA procedures.
• Oversee the document control process, GxP training program, employee training records, and GxP records/archive processes.
• Ensure controlled documents, training records, and quality records are maintained in compliance with applicable regulatory requirements and internal procedures.

Regulatory Submissions and Inspection Readiness

• Support regulatory submissions, including IND, IMPD, BLA/MAA, INAD, and NADA related submissions, by reviewing or contributing Quality input, documentation, and quality strategy.
• Prepare for, coordinate, host, and support regulatory agency inspections, partner audits, and other external assessments of Rion’s Quality systems and GxP operations.
• Support regulatory readiness by ensuring Quality systems, documentation, investigations, vendor oversight, and product quality records are phase appropriate and inspection-ready.

People Leadership and Budget

• Lead, coach, and develop Quality professionals supporting Rion’s Quality systems and development programs.
• Assign work, establish priorities, provide feedback, support career development, and ensure appropriate staffing and capabilities within the QA function.
• Coordinate the QA budget and support resource planning to align with Rion’s strategic goals and program needs.

Leadership Responsibilities:

• Partner with Chief Regulatory Officer and functional leaders to implement, maintain, and continuously improve Rion’s Quality Management System applicable FDA-regulated activities required for the manufacturing, distribution, and future commercialization.
• Collaborate with functional department heads and cross-functional stakeholders to ensure applicable GxP activities are conducted in accordance with US and global regulations, ICH guidelines, international standards, and internal policies and procedures.
• Develop and execute QA organizational strategy to support corporate goals, program priorities, operational direction, and growth, and future commercialization.
• Identify, recruit, retain, coach, mentor and develop Quality Assurance personnel.
• Promote transparent, concise, and timely communication through department meetings, one‑on-one meetings, cross-functional forums, and other appropriate venues.
• Foster a culture of quality, accountability, collaboration, continuous improvement, and compliance.
• Maintain current knowledge of applicable regulatory requirements, guidance documents, industry standards, and compliance regulations

Minimum Qualifications

• At least 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including significant experience supporting development-stage biologics, regenerative medicine, cell-derived therapies, exosome/extracellular vesicle-based products, or other complex biologic products. An advanced degree may substitute for a portion of the required experience.
• Demonstrated experience providing quality leadership for late-stage clinical programs, including progression from Phase 3 through commercialization.
• Strong leadership skills with demonstrated experience managing, coaching, and developing high-performing QA teams in a fast-paced, matrixed environment.
• Deep knowledge of phase-appropriate quality systems, regulatory requirements and compliance expectations across clinical development, including GMP, GCP, GLP, pharmacovigilance/safety reporting, including 21 CFR Parts 210/211, 21 CFR Part 11, applicable biologics, veterinary, and blood/blood component regulations, FDA and EMA expectations, ICH Q7/Q8/Q9/Q10, ICH E6, and relevant EU GMP requirements.
• Demonstrated success in QA oversight of CDMOs, and CTLs, and other GxP vendors, including vendor qualification, audits, quality agreements, and vendor management activities.
• Proven expertise in deviations, investigations, root cause analysis, CAPA, change control, products complaints and Quality risk management.
• Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes.
• Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input.
• Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending and statistical analysis preferred.
• ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred. 

Rion recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue career path their goals, both at work and in their personal lives. We provide a very competitive compensation package with a unique culture focusing on development and wellbeing of our staff.