Senior R&D Quality Officer, Product Development Quality Assurance

Added
21 days ago
Type
Full time
Salary
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Related skills

tpm gmp qms capa 21_cfr_210_211

📋 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.
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