RemoteLeaf Logo
Log in Sign up

Director, Clinical Quality Assurance (CQA)

2 hours, 4 minutes ago
United States
Full-time
Lead
QA Engineer
Quality Assurance and Testing
GCP
Apply Now
Immunovant

Immunovant

Pharmaceuticals
51-250
Founded 2018
$725M raised
View All Jobs 4

Description

  • Author, maintain, and implement study-specific Clinical Quality Audit Plans for assigned clinical programs and trials.
  • Represent Quality in cross-functional clinical program and study team meetings and provide GCP compliance guidance.
  • Identify, mitigate, and escalate clinical quality risks across all phases of clinical development.
  • Maintain oversight of quality activities related to vendor management, study conduct, and study documentation.
  • Author and review controlled QMS documents, including SOPs, in line with global regulatory requirements.
  • Oversee timely handling of deviations, investigations, CAPAs, and change controls.
  • Participate in risk review meetings and review study risk management materials.
  • Conduct QA reviews of essential study documents such as clinical protocols, study plans/manuals, and investigator brochures.
  • Collaborate with internal and external stakeholders to resolve GCP quality issues and strengthen compliance.
  • Support inspection readiness and manage inspection preparation for sponsor, site, and vendor inspections.

Requirements

  • Bachelor’s degree in STEM or an allied medical field such as Nursing or Pharmacy.
  • At least 7 years of GCP Quality Assurance, Quality Management, or Clinical Compliance experience in Phase 1–4 clinical trials, including non-interventional studies.
  • Experience in immunology trials is strongly preferred.
  • Strong working knowledge of global GxP regulations and drug development requirements, particularly FDA, EU, and ICH regulations and guidelines.
  • Direct experience with competent authority inspections, including US FDA GCP BIMO inspections and Pre-Approval Inspections (PAIs).
  • Progressive leadership experience motivating teams and delivering strong operating results.
  • Comprehensive understanding of how quality functions intersect with clinical and business functions such as CMC, audit management, vendor management, biostatistics, clinical operations, data management, drug safety, regulatory, supply chain, and program management.
  • Excellent written and verbal communication skills.
  • Strong teamwork, interpersonal, and negotiation skills.
  • Ability to prioritize multiple projects and work effectively under short deadlines in a fast-paced environment.

Benefits

  • Salary range of $210,000 to $235,000 USD.
  • Equity may be provided as part of the total compensation package.
  • Medical, dental, and vision coverage.
  • 401(k) benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Remote-based role with flexibility to work from home.
  • Opportunity for domestic and international travel, up to 25%.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Devsu

QA Engineer (Manual & Automation)

Devsu 51-250 Internet Software & Services

Devsu is seeking a QA Engineer to own automation, API, and performance testing for modern web applications in an agile delivery environment.

United States Latin America Full-time Senior QA Engineer
Agile CI/CD Gatling GCP Git GitHub JavaScript JMeter K6 Playwright Postman REST API TypeScript
36 minutes ago
Bounteous

QA Analyst

Bounteous 1K-5K Internet Software & Services

Bounteous is hiring a remote contract QA Analyst in Mexico to validate data pipelines and reporting for its Data & AI and Cloud technology work.

Mexico Contract Junior QA Engineer
Cybersecurity Looker Python SQL Tableau
1 hour, 20 minutes ago
Anduril Industries

Lead Quality Inspector (2nd Shift)

Anduril Industries 1K-5K Aerospace & Defense

Anduril Industries is hiring a Lead Quality Inspector to lead inspection operations for advanced unmanned aircraft systems and other defense assets within its manufacturing team.

United States Full-time Senior QA Engineer
$71k-$96k
1 hour, 33 minutes ago
Honda Ridgeline Owners Club Forums

Senior Staff Performance Engineer

Honda Ridgeline Owners Club Forums Professional Services

Ridgeline is hiring a Senior Staff Performance Engineer to lead platform-wide performance work for distributed systems, focusing on scalability, reliability, and cost efficiency across engineering teams.

Ireland Lead QA Engineer Software Engineer
Kubernetes
2 hours, 4 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers