Senior Quality Control & Assurance Leader | GMP | QMS | Regulatory Compliance

Designed and implemented the Quality Control laboratory and processes in compliance with GMP, aligned with the overall QMS within a CDMO environment. Managed quality events (deviations, CAPA, OOS, change control), ensuring effective root cause analysis and risk mitigation. Supported regulatory inspections and audits, ensuring inspection readiness and compliance. Collaborated cross-functionally with QA and manufacturing to ensure consistent quality oversight. Led and developed the QC team, promoting a strong quality culture.

Oversaw QC activities within clinical trial environments under ICH guidelines, ensuring regulatory compliance. Reviewed protocols, reports, and stability programs to ensure data integrity and quality standards. Contributed to quality documentation and compliance processes within a regulated environment.

Managed quality events within the QMS, ensuring GMP compliance. Reviewed batch records and QC documentation to ensure data integrity and regulatory alignment. Supported Product Quality Reviews (PQRs) and documentation management. Coordinated cross-functional quality and compliance activities.