ROLL TENDER

Qualifications

• Masters in Science, Technology, Business Administration, or Engineering (any)

Responsibilities

Support Quality Assurance and regulatory support across pharmaceutical, biotechnology, and contract research organizations (CROs), ensure compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Distribution Practices (GDP) regulations, manage international audits, oversee Corrective and Preventative Actions (CAPA), and perform electronic Trial Master File (eTMF) audits.

Support GMP biologics manufacturing with exposure to viral vector processes, aseptic operations, and complex cell-based systems.

Develop and support audit programs, monitor compliance metrics, and implement data-driven process improvements aligned with FDA, European Medicines Agency (EMA), International Organization for Standardization (ISO), and International Conference on Harmonization (ICH) standards, cross-functional collaboration.

Pay

$98,384.00/Yr.