Associate Director, External Quality

Posted 1hrs ago

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Job Description

Associate Director managing external quality oversight for Animal Health. Leading quality team across third-party partners in North America, ensuring compliance with company standards and regulations.

Responsibilities:

  • Lead external quality management and oversight of third-party manufacturing partners and CMOs
  • Serve as the Quality point of contact for external partners and internal stakeholders
  • Lead external manufacturing Quality team in Mexico and Canada for review, packaging and release for all local and imported products
  • Ensure partner compliance with GMP requirements, Quality Agreements, and commercial commitments
  • Oversee batch review, product release, change control, validation, audits, and remediation activities
  • Support quality system improvement, risk management, and continuous improvement initiatives
  • Manage team performance, budget, and headcount planning
  • Partner cross-functionally to support operational excellence, compliance, and supply continuity

Requirements:

  • 10+ years of experience in a pharmaceutical company and/or External Manufacturing Organization
  • 2+ years of direct people leadership experience
  • Proven remote management, team leadership, and performance accountability skills
  • Strong background in Quality Systems, QA/QC, global GMP, and regulatory requirements
  • Demonstrated experience in external quality management and third-party oversight
  • Strong problem-solving, risk management, communication, negotiation, and influencing abilities

Benefits:

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays, vacation, and compassionate and sick days