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Associate Director Quality Assurance Third Party Quality Management - Hybrid

đź•’ 8 days ago
Audit ManagementBatch ReleasesCompliance InvestigationsDeviation Management

📜 Description

  • Act as a Lead Quality Liaison for the Quality Oversight of External Entities/CMOs.
  • Manage the quality oversight of nominated Third-Party Vendors in the Clinical Finished Goods Platform.
  • Lead internal contractor issue investigations and resolution teams.
  • Collaborate closely with external contractor quality and technical personnel.
  • Develop key quality performance metrics and lead quality oversight projects.
  • Attend oversight and business review meetings to discuss projects and quality compliance.

🛠️ Requirements

  • Bachelor’s Degree in Pharmacy, Biology, Engineering, Chemistry or related field.
  • Minimum of ten (10) years of relevant experience within the pharmaceutical industry.
  • Strong scientific/technical knowledge and experience in R&D activities.
  • Ability to interact with scientific subject matter experts.
  • Experience in quality disposition and final batch release.
  • Strong compliance knowledge of regulations and GMPs.

✨ Benefits

  • Comprehensive medical
  • Dental
  • Vision healthcare benefits
  • Retirement benefits including 401(k).
  • Paid holidays
  • Vacation
  • Sick days
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