Senior R&D Quality Officer, Product Development Quality Assurance

📋 Description

• GMP batch documentation review and clinical supply disposition for NBE, NCE, ATMP programs
• Provide strategic quality leadership and mentorship within PDQA
• Review/approve batch records, assess changes, ensure traceability and compliance
• Lead deviation/investigation activities and CAPA planning
• Manage TPM and supplier quality oversight, quality agreements, and performance
• Report PDQA metrics and maintain inspection readiness

🎯 Requirements

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Pharmacy, or Chemical Engineering; MS/PhD
• 4–6 years QA in pharma/biotech; 8+ years preferred
• Knowledge of GMP for biologics, small molecules, ATMPs; ICH Q7/Q10, 21 CFR 210/211, EU GMP
• Experience reviewing GMP batch records and electronic batch records; strong QA judgment
• Strong communication, cross-functional collaboration, and prioritization skills
• Experience with TPM quality oversight and supplier qualification

🎁 Benefits

• Competitive compensation and benefits package
• Eligible for long-term incentive programs
• Paid time off, medical/dental/vision insurance, 401(k)