The responsibilities cover the quality aspects of data integrity, GMP computerized systems, master data management and laboratory instrumentation / systems, and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.

• Act as a change driver and strategic lead to site processes within the global Quality Management System (QMS) framework.
• Influence the organizational future through review and approval of all quality-related activities, such as policies, procedures, plans, protocols, requirements, reports, deviations and changes, as well as contributing to site inspection readiness.

• Introduce strategic initiatives on site, driving standardization across the GMP environment for computerized systems and data integrity, and representing DDQ in global governance meetings for data integrity, computerized system validation, master data management and lab instrumentation / systems.
• Promote cGMP and Data Integrity awareness and support a culture of continuous improvement. Help develop and maintain training on computerized systems validation, data integrity and internal procedures.
• Work together with the business to resolve regulatory non-conformances for cGMP computerized systems and data integrity in a way that ensures business efficiency and compliance. Drive improvements on both a local and global level, based on emerging trends, compliance gaps and system weaknesses.
• Act as a representative for DDQ management in site- and above-site meetings as needed.