Senior Clinical Quality Lead: Cell Therapy GCP (Remote)

Aurion Biotech; United States; Remote; USD 89,000 - 109,000; Full time

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

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.