Hybrid Associate Director, Clinical Quality Assurance

Posted 18 hours ago

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About the role

  • Provide Clinical Quality Assurance (GCP) Subject Matter Expertise (SME) to QED clinical study teams
  • Work closely with clinical study teams to ensure/coordinate appropriate documentation of quality event management, including corrective action and preventive action (CAPA) plans
  • Support the management, maintenance, and evaluation of QED's Quality Management System and processes for continuous improvement
  • Lead small-scale process improvement projects, as needed
  • Provide clinical quality assurance SME review of clinical protocols, and other clinical trial-related documents
  • Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
  • Provide support for audits and inspections conducted by external sources (e.g., health authorities) as applicable
  • Provide support for quality metrics and performance indicators to monitor the effectiveness of clinical quality assurance activities.
  • Other duties as assigned or required

Requirements

  • Bachelor's degree in a scientific discipline or equivalent experience
  • Minimum of 10 years of experience in a GCP practice area; Clinical Quality Assurance or similar role preferred
  • Knowledge of applicable GCP guidelines (e.g., CFRs and ICH)
  • Ability to build relationships and work collaboratively with a variety of individuals within the department, company, and external vendors
  • Ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
  • Strong negotiation skills, flexibility, and ability to provide a solution-based approach to emerging challenges
  • Attention to detail and proper use of tools for information processing and electronic quality management systems

Benefits

  • Market leading compensation
  • 401K with 100% employer match on first 3% & 50% on the next 2%
  • Employee stock purchase program
  • Pre-tax commuter benefits
  • Referral program with $2,500 award for hired referrals
  • Comprehensive health care with 100% premiums covered - no cost to you and dependents
  • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
  • Hybrid work model - employees have the autonomy in where and how they do their work
  • Unlimited flexible paid time off - take the time that you need
  • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
  • Flex spending accounts & company-provided group term life & disability
  • Subsidized lunch via Forkable on days worked from our office

Job title

Associate Director, Clinical Quality Assurance

Job type

Experience level

Senior

Salary

$166,994 - $197,070 per year

Degree requirement

Bachelor's Degree

Location requirements

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