Senior Quality Assurance Specialist (CMC)

Role: Senior Quality Assurance Specialist overseeing GMP quality systems across biopharma CMC development, including manufacturing, QC, and analytical development, supporting both development and commercial programs. Responsibilities: provide quality oversight for drug substance and drug product manufacturing (including external partners and CDMOs), review GMP documentation, support batch disposition, facilitate technology transfer, and ensure regulatory compliance through audit readiness and CAPA management. Participate in process validation, change control, deviation investigations, and continuous improvement of QMS processes. Requirements: Bachelor’s in Chemistry, Pharma Sciences, Engineering or related; 5+ years GMP QA experience in biotech/pharma, with strong knowledge of FDA/EMA cGMP regulations and ICH guidelines (Q7, Q8, Q9, Q10). Experience in pharmaceutical manufacturing oversight, GMP documentation review, and regulatory inspection preparedness. Preferred: advanced degree, experience in CMC/analytical development, process validation, and working in both development and commercial GMP environments. HighValue: cGMP manufacturing oversight, regulatory inspection readiness, support for CMC/analytical development, validation, and external partner management. WorkSetup: not specified; operates in a dynamic, highly regulated pharmaceutical environment.