Senior leadership role responsible for leading and overseeing the global quality function across all Xerimis sites. Instrumental in driving a culture of quality excellence, ensuring compliance with regulatory requirements across all regions, and fostering continuous improvement initiatives to enhance product quality and patient safety.

Senior leadership role responsible for leading and managing the quality function across European operations within the pharmaceutical organization. This role is instrumental in ensuring compliance with European GMP/GDP regulatory requirements, driving quality excellence, and fostering a culture of continuous improvement.

Responsible for providing both leadership, strategy and management for both ‘real time’ and Global Strategic Quality Operations for COVID-19 Vaccine Network Operations. Responsibilities included strategic resource planning, assignment, digital integration, process and procedural development, network communications. Held senior management responsibility and quality authority for assuring that the products supplied to patients were distributed in accordance with company and Industry standards and practices, product registration file and country specific requirements.

Senior Manager for GMP batch release Quality Assurance Officers performing EU and UK QP batch certification documentation review for multiple licenses. Managed batch release team (UK and EU Based) supporting virtual batch release activities, compliance systems and assigned project activities, including for corresponding cover for associated department people managers. Hosted and managed Competent Authority and corporate inspections, responses and commitments. Developed, deployed and monitored resources to meet business needs and department capacity. Assigned and measured actions associated with line reports to support business and departmental needs. Led in the resolution of quality related issues, in conjunction with the batch release Quality Officers, QPs, Regulatory, Supply Chain, Regulatory and Manufacturing / testing site stakeholders etc. (as required). Provided timely and continuous feedback to assist in continual improvement and right first-time levels to key stakeholders.

Responsibility for Quality oversight of Pfizer Exports (Netherlands), named as a Responsible Person for the Wholesale Dealer’s License and provided inspection readiness support. Established new Quality Management System, team and WDA license to support Pfizer Export business. Responsible for personnel management; hiring, development, goal setting, appraisals and appropriate actions where required. Conducting and supporting internal and external audits for GDP and GMP EU release activities. Management of agency and corporate inspections and commitments. Establishment and development of global process for global quality organisation. Project manager for integration and continuous improvement of GMP/GDP processes.

Responsible for critical transportation and product related defect investigations, reporting events to senior management (Notification to Management) and managing EMEA market actions (Health authority communications, recalls and customer communications). Management of a Quality Distribution team (for Quality holds, recalls and temperature control shipments), performing multiple warehouse visits, audits and attending QMR/QBR meetings. Product knowledge in medical device (electrical & single use consumables) and pharmaceutical product (sterile injectable generics and biologics) handling, transportation and storage. Named as the Responsible Person for two (2) Wholesale Dealer Authorisations (UK & Netherlands) to support global pharmaceutical product distribution.