Manager, Quality Assurance

Careaccess

Remote, US
Base: $85,000 - $110,000 usd py; bonus/equity: not...
Remote
Clinical trial experience required
Knowledge of gcp auditing techniques
Experience with internal and external audits
Care Access is seeking a Manager of Quality Assurance to ensure compliance with quality standards in clinical research. The role involves internal and external auditing, CAPA management, and promoting a culture of quality across the organization

Job Summary

  • The role drives quality management system activities including auditing, inspection readiness, and vendor review to ensure patient safety and data integrity.
  • This position requires supporting the organization's commitment to accelerating access to new medicines while maintaining rigorous global regulatory standards.
  • Employees receive comprehensive benefits including 100% employer-paid medical, dental, and vision insurance, along with a company-matched 401(k) plan.

Matching Summary

Match Score: 85

Care Access is seeking a Manager of Quality Assurance to ensure compliance with quality standards in clinical research. The role involves internal and external auditing, CAPA management, and promoting a culture of quality across the organization.

Salary

Base: $85,000 - $110,000 USD per year; Bonus/Equity: Not specified; Benefits: PTO, 100% paid medical/dental/vision, 401(k) match

Skills & Requirements

Must-have

  • Clinical trial experience required
  • Knowledge of GCP auditing techniques
  • Experience with internal and external audits
  • CAPA management and root cause analysis
  • Understanding of ICH GCP E6 guidelines

Nice-to-have

  • Interest in artificial intelligence applications
  • Openness to innovative research approaches
  • Strong communication skills for senior leaders
  • Experience with digital technologies
  • Certification as a clinical auditor

Key Requirements

  • Bachelor's degree preferred or equivalent experience
  • Minimum 1-3 years in clinical research QA or compliance
  • Required clinical trial experience at site, network, or CRO
  • Knowledge of 21 CFR Part 11 and Part 312
  • Ability to travel up to 35%

Work Rights

Not specified

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