CAPA Manager

Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.

Proven experience managing CAPA systems and leading investigations.

Demonstrated ability to analyze and interpret quality data, trend metrics, and identify systemic issues using analytical tools.

Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and Microsoft Office Suite; experience with data visualization or reporting tools (e.g., Excel advanced functions, Power BI) is a plus.

Serve as the CAPA Program Owner, ensuring compliance with corporate and regulatory guidelines.

Oversee day-to-day operation of the CAPA Quality System, including recurring CAPA meetings and timely closure of CAPAs.

Lead and facilitate investigations for deviations.

Review and approve CAPA documentation for completeness and accuracy.

Escalate quality issues to Sr.

Trend overall CAPA metrics and perform root cause analysis on system performance to identify systemic issues and drive continuous improvement.