Hybrid Director, Center Quality Ops

Posted last month

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About the role

  • Director of Quality Operations leading US plasma donor centers compliance with FDA and PPTA regulations. Overseeing quality operations and maintaining strong quality culture across the organization.

Responsibilities

  • Ensure all plasma donor centers comply with FDA and PPTA regulations
  • Lead and develop a national Quality Operations team
  • Ensure effective communication and collaboration with various departments
  • Maintain audit and inspection readiness across all centers
  • Oversee investigations, deviations, CAPAs, and product quality issues
  • Establish and track quality metrics, KPIs, and trends for Donor Centers
  • Promote a proactive quality mindset with strong ownership at Donor centers

Requirements

  • Bachelor’s in Life Sciences, Pharmacy, Biology, Nursing or related field (required)
  • Master’s degree preferred
  • Typically requires 10 years in GxP or plasma/biologics Quality roles
  • 5+ years leading multi-site Quality Operations teams
  • Strong inspection management experience (FDA, EMA, PPTA, CLIA/COLA, State, internal audits)
  • Experience with QMS systems (TrackWise, etc.)

Benefits

  • medical
  • PTO
  • up to 5% 401K match
  • tuition reimbursement

Job title

Director, Center Quality Ops

Job type

Experience level

Lead

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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