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The Product Quality Manager ensures the highest product quality throughout the product lifecycle and adheres to regulations and standards. This role involves collaboration with various departments for timely project completion, managing quality issues, supporting SOP development, conducting quality document reviews, and performing root cause investigations.

The QC Senior Scientist will conduct quality control analysis of various biotherapeutic products, ensuring compliance with GMP. Responsibilities include performing chromatographic testing, completing GMP documentation, collaborating on method qualification, conducting investigations, and supporting lab operations. The role also involves mentoring less experienced staff and participating in audits and inspections.

Manage quality compliance activities, coordinate audits and inspections, develop inspection readiness plans, ensure regulatory compliance, and drive continuous improvement initiatives within the Quality Compliance programs.