Assoc Director, GMP Quality Assurance

Responsibilities

• Support GMP clinical manufacturing operations, including product release and analytical data review
• Collaborate with Qualified Persons for batch certification and release in the EU
• Manage QA contractors supporting GMP operations
• Approve product disposition and review deviations, complaints, and change controls
• Liaise with internal experts and third-party vendors to ensure quality compliance
• Provide quality oversight for clinical program supply chain demands
• Develop quality agreements and support compliance during audits

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred
• 8+ years of industry experience in small molecule drug development and GMP QA
• At least 10 years in GxP pharmaceutical environments with progressively responsible roles
• Hands-on experience in quality oversight for solid oral dosage and biologics manufacturing
• Familiarity with electronic document management and quality management systems

Benefits

• Comprehensive paid time off policy including vacation and sick leave
• Medical, dental, and vision insurance plans
• Short- and long-term disability coverage, plus life insurance options
• Flexible spending accounts for health and commuting expenses
• 401(k) plan with company contributions and an employee stock purchase program