Senior R&D Quality Officer, Product Development Quality Assurance

📋 Description

• Support GMP batch documentation review and clinical supply disposition for NBE, NCE, ATMP programs.
• Provide QA leadership and mentorship across TPMs and AbbVie sites to ensure GMP compliance.
• Partner with cross-functional teams to maintain quality standards and support development timelines.

🎯 Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Pharmacy, or Chemical Engineering; MS/PhD
• 4–6 years QA experience in pharma/biotech; 8+ years preferred.
• Working knowledge of global GMP for drug substance/product; ICH Q7/Q10, 21 CFR 210/211, EU GMP.
• Experience reviewing GMP batch records and electronic batch records; capable of risk-based
• Strong communication to influence cross-functional decisions and manage multiple priorities.

🎁 Benefits

• Quality system improvements and ongoing training for QA staff.
• Opportunities for professional development and leadership in a global QA environment.