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Associate Director Quality

Merck · West Point, PA

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QualityFull-time$129k–$203kCompany career page

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Role summary

Associate Director of Quality at Merck's West Point, Pennsylvania site overseeing quality systems, compliance, and a team of Quality Specialists. Responsible for regulatory adherence, documentation management, training, and quality improvement initiatives across manufacturing operations.

What they're looking for

  • Bachelor's degree in science or engineering with 8+ years in Operations, Quality, Technical Operations, or related functional area
  • Master's degree in science or engineering with 6+ years in relevant functional area
  • Minimum 2 concurrent years Quality experience in GMP-controlled environment
  • Strong knowledge of cGMP, FDA, and EMEA regulatory standards with demonstrated compliance mindset
  • Proven analytical and critical thinking abilities with ability to apply technical concepts
  • People leadership experience; preferably 2+ concurrent years managing direct reports

What you'll be doing

  • Provide quality direction and oversight for site quality systems including training, documentation, and compliance management
  • Manage team of Quality Specialists partnering with operations to ensure regulatory adherence and approved process compliance
  • Drive quality improvement activities and ensure organizational alignment on assigned priorities
  • Oversee training, Standard Operating Procedures, Master Batch Records, Change Control, and Risk Management initiatives
  • Lead Annual Product Reviews and Quality Management System execution to maintain regulatory compliance

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Date posted4 days ago
Last source check1 day ago
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