Copy of Senior R&D Quality Officer, Product Development Quality Assurance

📋 Description

• Role focuses on GMP batch documentation review and clinical supply disposition for NBE, NCE, and
• Provides strategic quality leadership and mentorship within the PDQA team
• Reviews batch records and QA documentation at TPMs and AbbVie sites to ensure GMP compliance
• Collaborates with TPMs, AbbVie sites, and cross-functional teams to maintain supply continuity
• Leads deviations, investigations, CAPA, and risk-based quality assessments
• Supports inspection readiness and continuous GMP improvement initiatives

🎯 Requirements

• Bachelor’s degree required (Biology, Chemistry, Biochemistry, Pharmacy, or Chemical Engineering)
• 4–6 years QA experience; 8+ years preferred
• Knowledge of GMP for drug substances/products; ICH Q7/Q10, 21 CFR Parts 210/211, EU GMP
• Experience reviewing GMP batch records; familiarity with electronic batch records/QMS
• Strong communication and cross-functional collaboration skills
• Experience with TPM quality oversight and supplier qualification

🎁 Benefits

• Competitive compensation package
• Paid time off and health insurance options
• 401(k) plan and long-term incentive programs