Assoc Director, GMP Quality Assurance

📋 Description

• Support GMP clinical manufacturing operations, including review/approval of Manufacturer master and
• Collaborate with Qualified Persons (QPs) for batch certification and release of drug product and
• Provide quality oversight for meeting clinical program supply demands domestically and
• Develop, review, and support compliance to quality agreements and other customer contracts with
• May support internal and external compliance audits; assist with vendor management for GMP vendors
• Assist with selection and qualification of GMP vendors and participate in Business Review Meetings

🎯 Requirements

• Bachelor of Science in Biology, Chemistry, Physical Sciences, or related field and/or equivalent
• Advanced degree in Pharmaceutics, Chemistry or related field with 8+ years in pharmaceutical drug
• 8-10 years in GxP pharma environment with progressively responsible Quality roles; GMP QA
• Experience overseeing solid dosage and Biologics manufacturing quality; strong regulatory
• Experience with electronic document management systems and Quality Management System software a
• Strong communication, organizational, and collaboration skills; ability to multi-task in a

🎁 Benefits

• Annual bonus and equity grant at hire and annually; stock purchase options in the future.
• Paid time off, holidays, sick leave, medical/dental/vision plans, disability coverage
• Employee assistance program and other comprehensive benefits.