Christina Monica

Lead and contribute to R&D Quality projects, focusing on internal PV process audits and external vendor audits. Responsible for audit program coordination, training auditors, and ensuring compliance with regulatory standards. Manage audit activities and prepare the company for regulatory inspections.

Supported QA oversight for clinical trials and operations, focusing on PV compliance and quality management system development. Contributed to risk-based QA audits and provided compliance support to clinical study teams.

Managed procedural document development and improvement projects to align with regulatory requirements. Coordinated cross-functional reviews and ensured effective communication and implementation of process changes.

Oversaw compliance monitoring systems for PV activities and served as the main contact for audits and inspections. Managed procedural document reviews and coordinated CAPA plans post-inspections.

Led DSP compliance activities and supported CAPA implementation for PV and GCP commitments. Coordinated cross-functional activities to ensure compliance during audits and inspections.

Assisted in continuous process improvement initiatives within Global Pharmacovigilance to enhance compliance activities and ensure inspection readiness.

Executed the dissemination of adverse event information to regulatory agencies and partners for consumer healthcare products, ensuring compliance with safety reporting requirements.

Grade: 3.68

Completed an MBA with a focus on General Management, achieving a GPA of 3.68. The program emphasized leadership, strategic thinking, and business operations, preparing graduates for advanced roles in various industries.

Earned a Bachelor of Arts in Cell Biology and Neuroscience with a minor in Women and Gender Studies. The program provided a comprehensive understanding of biological sciences while integrating social perspectives.