Position Overview
Job Title: Quality ManagerJob Description
The Quality Manager provides comprehensive oversight of Quality Control (QC) testing activities and contract testing laboratories, ensuring robust analytical methods, compliant product release, and alignment with global regulatory expectations. This role leads the governance of QC documentation, stability programs, and quality systems, while partnering closely with internal teams and external CDMOs and CTLs to maintain high standards of product quality and patient-focused outcomes.
Responsibilities
+ Provide end-to-end oversight of contract testing laboratories (CTLs) and QC testing activities, ensuring all work complies with applicable GxP and GMP requirements.
+ Oversee the development, review, and approval of Justification of Specifications (JOS), product specifications, and Certificates of Analysis (CoA) to support compliant product release.
+ Ensure comprehensive lifecycle management and validation of analy...