Senior Specialist, QA Operations

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology.

Requirements

• BS/MS degree in science related field
• Minimum of 5 years’ experience in quality assurance and/or compliance roles in the pharmaceutical industry
• Experience working in a GMP aseptic manufacturing environment
• Experience working with FDA or other regulatory authorities
• Expertise in GMP, Quality, material and product disposition
• Strong capability in authoring and critically reviewing investigations
• Detail-oriented with demonstrated applications in problem solving and decision-making abilities
• Team player who can work independently to achieve objectives
• Excellent verbal and written communication skills
• Knowledge of US, EU and rest-of-world cGMP regulations and guidance
• Knowledge and proven experience in FDA, EMA, or other regulatory authority
• Well-practiced in exercising sound judgment in decision-making

Benefits

• Health Coverage
• Wellbeing Support
• Financial Well-being and Protection
• Paid Time Off
• 401(k) plan
• Short- and long-term disability
• Life insurance
• Accident insurance
• Supplemental health insurance
• Business travel protection
• Personal liability protection
• Identity theft benefit
• Legal support
• Survivor support