Director, Clinical Quality Assurance

Headlandsresearch

Remote
Remote
Gcp and regulatory guidelines adherence
Quality assurance and training programs
Oversight of inspections and audits
The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process

Job Summary

  • The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process.
  • This individual will oversee quality and training functions for the organization including, but not limited to, the development and maintenance of quality assurance and training programs and policies, oversight of inspections and audits, quality diligence for acquired sites, and management of SOP’s and quality documents to ensure GCP and all regulatory guidelines are adhered to.
  • In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites, providing hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution.

Matching Summary

The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process.

Skills & Requirements

Must-have

  • GCP and regulatory guidelines adherence
  • Quality assurance and training programs
  • Oversight of inspections and audits
  • SOP development and maintenance
  • Patient safety during trials

Nice-to-have

  • Agility and collaboration
  • Impact process development
  • Critical thinking and problem-solving

Key Requirements

  • Bachelors degree in business or health-related field
  • 5+ years clinical trials experience
  • 3+ years team leadership experience
  • Fundamental knowledge of US regulatory standards

Work Rights

Not specified

Tailored Resume

Cover Letter