Vendor Quality Management Director

New

Skills

Contract Negotiation Regulatory Compliance

Job Overview

Lead vendor qualification and lifecycle management for Contract Manufacturing Organizations (CMOs) and suppliers. Define vendor risk classification criteria and oversight frequency. Oversee vendor assessments and approval processes. Monitor vendor performance with quality metrics. Lead vendor transitions or discontinuations as needed. Develop and maintain Quality Agreements aligned with contracts.

Responsibilities
  • Lead vendor qualification and lifecycle management.
  • Define vendor risk classification criteria and oversight frequency.
  • Oversee vendor assessments and approval processes.
  • Monitor vendor performance with quality metrics.
  • Lead vendor transitions or discontinuations as needed.
  • Develop and maintain Quality Agreements aligned with contracts.
Requirements & Qualifications
  • Bachelor’s degree in scientific discipline or equivalent.
  • 12+ years pharma/biotech quality with vendor oversight.
  • Strong knowledge of cGMP and global regulatory expectations.
  • Experience managing vendor audit programs.
  • Experience drafting and negotiating Quality Agreements.
  • Experience supporting regulatory inspections.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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