Senior Clinical Quality Associate

Overview

This range is provided by Aurion Biotech. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

JOB TITLE: Senior Clinical Quality Associate

LOCATION: Remote - candidates based in the following states will be considered: IN, MA, NC, NH, NM, NY, PA, SC, SD, TX, KY, NJ or WA.

SALARY RANGE: $89,000 to $109,000. The midpoint of the range is $98,000. The ideal candidate would be hired at or around the midpoint.

ABOUT THE POSITION

This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As a Senior Clinical Quality Associate, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States.

The primary purpose of the Senior Clinical Quality Associate is to drive and lead Clinical Quality Assurance (CQA) activities in support of clinical study conduct and provide QA expertise to ensure adherence with applicable regulatory requirements and Aurion policies and procedures.

KEY RESPONSIBILITIES

• Serve as the CQA Lead on programs, including those requiring unmasked CQA roles
• Provide monitoring and interpretation of FDA, ICH-GCP, EMA, and other relevant regulatory requirements, ensuring sponsor operations remain compliant and inspection-ready
• Lead the development, implementation, and improvement of clinical and other SOPs
• Provide guidance on remediation, preventive, and corrective action plans to ensure compliance with GCP and regulatory requirements
• Develop, maintain, and oversee a Quality Management Plan for each study, detailing quality oversight strategies, risk mitigation, critical process control points, and compliance monitoring
• Perform vendor qualification and management activities related to clinical vendors
• Conduct audits of clinical vendors and clinical sites
• Review/Approve clinical documentation, ensuring accuracy and compliance
• Coordinate site and company inspection readiness
• Support quality performance initiatives and continuous improvement efforts
• Compile CQA metrics for Quality Management Review
• Conduct and document training for clinical and cross-functional teams on SOPs, GCP, and regulatory updates
• Other duties as assigned

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline preferred
• 3-5 years of full-time GCP Quality Assurance experience

REQUIRED

SKILLS AND ABILITIES

• Strong working knowledge of FDA regulations, GCP standards, and current industry practices within biotechnology
• Demonstrated ability to rapidly adapt to changing priorities and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all GCP and regulatory requirements are met
• Experience with cell therapy clinical studies is preferred
• Ability to identify and escalate problems and follow-through with corrective actions
• Excellent record keeping and documentation skills
• Strong communication skills, both verbal and written, with the ability to concisely present information in cross-functional settings
• Experience working with CROs preferred
• Proficient use of MS Office products
• Ability to work effectively both independently and with other team members

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA.

Aurion Biotech is the recipient of the Prix Galien award for best start-up in…