Remote Senior Clinical QA Manager

Elevar Therapeutics; United States; Remote; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Retirement plan

Time off

Voluntary benefits

Job summary

Elevar Therapeutics seeks a Senior Manager, Clinical Quality Assurance to lead quality oversight of clinical activities and ensure trials meet GCP and company SOP standards. This remote-based role is located in the United States, interfacing with Drug Development and corporate QA to audit vendors, sites, and internal processes.

The role requires extensive CQA experience, strong knowledge of GCP, ICH guidelines, and regulatory inspections, plus the ability to work cross-functionally and drive

Qualifications

• Bachelor’s degree with [12] years of experience or Master’s with 5+ years, plus cross‑functional leadership.
• Extensive Clinical Quality experience in biotech/pharma and remote teamwork.
• Deep knowledge of GCP, ICH guidelines, FDA CFR and regulatory frameworks.

Responsibilities

• Oversee clinical quality assurance activities to ensure GCP compliance.
• Interface with Drug Development and QA to audit vendors, sites and trials.
• Draft and manage quality plans, risk management, and inspection readiness.
• Prepare materials for regulatory submissions and support audit findings.
• Provide cross‑functional clinical operations input and drive corrective actions.

Skills

GCP Knowledge

ICH Guidelines

FDA CFR knowledge

Regulatory inspections

QA Applications/Databases

Problem Solving

Education

Bachelor’s degree

Master’s degree (preferred)

Tools

QA Software

Job description

Elevar Therapeutics seeks a Senior Manager, Clinical Quality Assurance to lead quality oversight of clinical activities and ensure trials meet GCP and company SOP standards. This remote-based role is located in the United States, interfacing with Drug Development and corporate QA to audit vendors, sites, and internal processes.

The role requires extensive CQA experience, strong knowledge of GCP, ICH guidelines, and regulatory inspections, plus the ability to work cross-functionally and drive