Senior Manager/Director of Quality
July 24
🏢 In-office - Long Island
Description
• Responsible for overseeing the quality and compliance of laboratory operations with GLP/GCLP regulations. • Supports the laboratory with the build out of quality systems for GLP lab operations. • Leads internal audits and hosts client audits. • Prepares QA statements for GLP study reports. • Ensures sponsor inspection readiness.
Requirements
• A BS and/or MS degree in a scientific or technical field • At least 5 years of experience in Quality Assurance working at a CRO, pharma, biotech or diagnostic lab • Prior audit and GLP review experience • In-depth knowledge and experience with GLP and/or GCP regulations and industry standards (EPA, OECD, FDA, EU guidance) • Excellent communication skills and work well under pressure in a team environment • Experience in histology, histotechnology, and IHC are highly desirable. • Lab management experience is a plus.
Benefits
• 100% coverage on employee health, vision, and dental insurance, partial coverage for family • Memberships to TeleDoc and TalkSpace (one year) • Parental leave • NY Commuter benefits • Flexible Spending Accounts (FSA) and Health Savings Account (HSA) • Retirement planning (401k) • Onsite gym membership and commuter showers • Team building events outside the office
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