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Quality Manager

14 hours, 3 minutes ago
United States, Canada
Full-time
Senior
Manual QA Tester
Quality Assurance and Testing
Apply Now
Headlands Research

Headlands Research

Headlands Research is a multinational integrated clinical trial site organization that specializes in the recruitment and retention of diverse populations for clinical trials, leveraging extensive site databases and partnerships with physicians to enha...

Biotechnology
51-250
Founded 2018
View All Jobs 2

Description

  • Create and maintain SOPs, work instructions, and guidance for network and site-level compliance with ICH-GCP and applicable regulations.
  • Review and update existing SOPs and guidance to align with regulatory requirements and network standards.
  • Support development and delivery of training events and training materials for network and site employees.
  • Conduct internal study reviews to assess compliance, identify risk, and document findings and corrective actions.
  • Partner with operations teams to remediate noncompliance and implement preventive actions.
  • Assist site operations with developing, implementing, and tracking CAPA plans within the assigned region.
  • Assess site risks regularly and report them to operations leadership.
  • Conduct quality reviews of external sites for M&A due diligence and support integration of newly acquired sites.
  • Attend external audits and provide updates to internal leadership.
  • Help assess employee performance against quality standards and support inspection readiness.

Requirements

  • 5+ years of experience in the clinical research industry.
  • Bachelor’s degree or equivalent required; an Associate’s degree with 5 years of equivalent experience will be considered.
  • Certification by a professional clinical research organization preferred.
  • Strong knowledge of current federal, state, provincial/local regulations and GCP.
  • Experience in cGXP work environments is highly adaptable and relevant.
  • Comfortable traveling up to 30% domestically and internationally, including Canada.
  • Extreme attention to detail.
  • Strong communication, organizational, and interpersonal skills.
  • Ability to work effectively with a diverse team and with autonomy or direction as needed.
  • Proficient computer skills, including MS Office.
  • Ability to build rapport with employees and external clients.

Benefits

  • Remote pay range of $110,000 to $140,000 USD.
  • Reasonable accommodation support for individuals with disabilities during the application process.
  • Equal Opportunity Employer commitment.
  • Opportunity for professional development through continuing education and staying current on regulatory and industry best practices.

Interested in this position?

Apply directly on the company website

Apply Now

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