Senior Clinical Quality Associate

Aurion Biotech

United States

Remote

USD 89,000 - 109,000

Full time

14 days+

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Benefits offered by this job

Robust health insurance

401(k) matching

Generous PTO

Paid parking

Team events

Job summary

A clinical-stage biotechnology firm is seeking a Senior Clinical Quality Associate to lead quality assurance activities in clinical research. This remote role requires strong knowledge of FDA regulations and GCP standards, with opportunities for growth in the innovative field of cell therapy. The ideal candidate will have a Bachelor’s degree and relevant QA experience, along with excellent communication skills and the ability to work independently.

Qualifications

Bachelor’s degree in a relevant field preferred.
Demonstrated ability to rapidly adapt to changing priorities.

Responsibilities

Serve as the CQA Lead on programs.
Ensure sponsor operations remain compliant and inspection-ready.
Lead the development and improvement of clinical SOPs.

Skills

Strong working knowledge of FDA regulations

GCP standards

Excellent record keeping and documentation skills

Strong communication skills

Ability to work effectively both independently and as a team member

Education

Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline

3-5 years of full-time GCP Quality Assurance experience

Tools

MS Office products

Job description

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 biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

Seniority level