Clinical Quality Lead

argenx

Base: $152,000.00 - $209,000.00 usd annually; bonu...
Onsite
Minimum 5 years quality assurance experience
In-depth knowledge of us and eu regulations
Ich gcp guidelines expertise
The Clinical Quality Lead is responsible for driving real-time quality oversight and consistent high-quality standards for global clinical trials

Job Summary

  • The Clinical Quality Lead is responsible for driving real-time quality oversight and consistent high-quality standards for global clinical trials.
  • This role involves leading audit programs, managing vendor relationships, and ensuring compliance with GCPs and regulatory requirements.
  • The position offers a comprehensive benefits package including retirement savings plans, health benefits, and eligibility for short-term and long-term incentive programs.

Matching Summary

The Clinical Quality Lead is responsible for driving real-time quality oversight and consistent high-quality standards for global clinical trials.

Salary

Base: $152,000.00 - $209,000.00 USD annually; Bonus/Equity: Eligible for short-term and long-term incentive programs; Benefits: Comprehensive package including retirement savings and health benefits

Skills & Requirements

Must-have

  • Minimum 5 years quality assurance experience
  • In-depth knowledge of US and EU regulations
  • ICH GCP Guidelines expertise
  • FDA, EMA, MHRA inspection experience

Nice-to-have

  • Knowledge of global pharmacovigilance regulations
  • Ability to influence without direct leadership
  • Experience in a dynamic biotech environment
  • Mentoring junior quality leads capability

Key Requirements

  • MS Degree required
  • Minimum 7 years clinical trial experience
  • Minimum 5 years quality assurance experience
  • Inspection experience with FDA, EMA, MHRA, or PDMA

Work Rights

Not specified

Tailored Resume

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